NAME OF THE MANUFACTURER: - ABC

 

RISK ANALYSIS REPORT

(RELEVANT STANDARD ISO 14971)

PRODUCT: - STERILE SINGLE USE INTRA VENOUS CANNULA

BRAND: -

PERFORMED BY: -

 

   

 

   

  

REVIEWED BY: -

                                 

                                     

                            

                              

APPROVED BY: -

                               

 

 

 

RISK ASSESSMENT

 

RISK LEVEL

1.   Nil

2.   Very low (Negligible)

3.   Low

4.   High

 

DEGREE OF ACCEPTABILITY

Level 1 - Acceptable with monitoring to maintain.

Level 2 - Acceptable with monitoring & scope for improvements.

Level 3 & 4 Not acceptable.

 

 

 

RISK ANALYSIS REPORT

PRODUCT: - STERILE SINGLE USE INTRAVENOUS CANNULA                                                PRODUCT FAMILY:

 

Potential Hazard

Description of specific hazards which may arise

Initial Risk Estimate

Mitigation Steps

Residuals risk After Mitigation

Comments, Test reports or References

 

 

1

2

3

4

Risk Status

 

1

2

3

4

Risk Status

 

1. Integrity of connection

a.   Hub and introducer needle

 

b. Wing and catheter

 

c. Filter and Luer lock cap

 

d. Blood stopper / Luer lock cap and hub.

1.      Separation from mating components during use.

 

2. Leakage

 

 

 

 

 

 

 

 

Not acceptable

1.Design of the components

 

2.  Process control

 

 

3. Product verification

 

 

 

 

 

 

 

Acceptable

Technical specification

Doc. #

 

 

 

 

Product measurement procedure Doc. # 

 

 

2.Incompatibility

1.      Reaction with medicaments

2.      Reaction with subject

 

 

 

 

 

 

Not acceptable

1. Material selection

2. Material evaluation before use

3. Certification by the material manufacturer

 

 

 

 

 

Acceptable

Material specification

 

 

Material evaluation procedure

Doc. #

 

 

 

 

 

Risk Level: - 1. Nil        2. Very Low (Negligible)                  3. Low        4. High

RISK ANALYSIS REPORT

PRODUCT: - STERILE SINGLE USE INTRAVENOUS CANNULA                                                PRODUCT FAMILY:

 

Potential Hazard

Description of specific hazards which may arise

Initial Risk Estimate

Mitigation Steps

Residuals risk After Mitigation

Comments, Test reports or References

 

 

1

2

3

4

Risk Status

 

1

2

3

4

Risk Status

 

3. Blockage

- No flow of blood in the needle at the time of veni puncture & failure to acertain access.

 

 

 

 

 

Not acceptable

1. In built system on assembly machine to detect blockage

2. Control & monitoring of silicon solution concentration

3. Product verification

 

 

 

 

 

 

 

 

- Process validation reports

 

 

- Product measurement procedure Doc. #

 

4. Corrosion of needle tube

Infection / Reaction

 

 

 

 

 

 

Not acceptable

1. Material selection

 

2. Testing

 

3. Storage instructions

 

 

 

 

 

 

Acceptable

 

 

 

 

 

 

 

 

 

- Material specification

- Material test procedure Doc. #

 

- Storage instruction on the shelf pack

 

Risk Level: - 1. Nil        2. Very Low (Negligible)                  3. Low        4. High

 

RISK ANALYSIS REPORT

PRODUCT: - STERILE SINGLE USE INTRAVENOUS CANNULA                                                PRODUCT FAMILY:

 

Potential   Hazard

Description of specific hazards which may arise

Initial Risk Estimate

Mitigation Steps

Residuals risk After Mitigation

Comments, Test reports or References

 

 

1

2

3

4

Risk Status

 

1

2

3

4

Risk Status

 

5. Catheter tip formation

a. Wall thickness

b. Tip not smooth

c. Overlapping of bevel by catheter

1. Peel back effect

 

 

2. Thrombophlebitis

 

 

 

 

 

 

Not acceptable

1. Tip design        

Specification

 

2. Process control

 

3. Inspection

 

 

 

 

 

Acceptable

 

 

 

 

 

 

 

 

 

- Related design drawing

- Process measurement procedure Doc. #

 

- Product measurement procedure Doc. #

 

ISO 10555 - 5

6. Valve fitment of injection port

 

 

 

 

 

 

 

 

 

Leakage

 

 

 

 

 

Not acceptable

1.  Design of valve & port

 

2.  Process control

 

3.  Inspection

 

 

 

 

 

 

 

Acceptable

- Related design drawing

 

- Process measurement procedure Doc. #

 

 

- Product measurement procedure Doc. #

 

 

Risk Level: - 1. Nil        2. Very Low (Negligible)                  3. Low        4. High

RISK ANALYSIS REPORT

PRODUCT: - STERILE SINGLE USE INTRAVENOUS CANNULA                                                PRODUCT FAMILY:

 

Potential   Hazard

Description of specific hazards which may arise

Initial Risk Estimate

Mitigation Steps

Residuals risk After Mitigation

Comments, Test reports or References

 

 

1

2

3

4

Risk Status

 

1

2

3

4

Risk Status

 

7. Components damaged

 

 

 

 

 

 

 

Not usable

 

 

 

 

 

Not acceptable

1. Component & process design

2. Process control

3.      Inspection

4.      Material handling

 

 

 

 

 

 

Acceptable

- Related design drawing

- Process measurement procedure Doc. #

 

- Product measurement procedure Doc. #

 

- Material handling procedure

8. Manufacturing environment & personal hygiene

Product contamination

 

 

 

 

 

Not acceptable

1. Design of manufacturing area

2. Validation of clean room

 

3. Routine maintenance & monitoring of clean room

4. Personal hygiene procedure

5. Monitoring of product bioburden

 

 

 

 

 

Acceptable

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

- Clean room validation procedure Doc. #

 

- Clean room entry procedure Doc. #

 

- Clean room cleaning procedure Doc. #

 

- Personal hygiene procedure Doc. #

 

- Bioburden test procedure

Doc. #

 

Risk Level: - 1. Nil        2. Very Low (Negligible)                  3. Low        4. High

 

RISK ANALYSIS REPORT

PRODUCT: - STERILE SINGLE USE INTRAVENOUS CANNULA                                                PRODUCT FAMILY:

 

Potential   Hazard

Description of specific hazards which may arise

Initial Risk Estimate

Mitigation Steps

Residuals risk After Mitigation

Comments, Test reports or References

 

 

1

2

3

4

Risk Status

 

1

2

3

4

Risk Status

 

9. Integrity of unit pack

 

Product rendered unsterile / contaminated

 

 

 

 

 

 

Not acceptable

 

 

 

 

 

 

1. Selection of packing material

2. Process validation

3. Product testing

 

 

 

 

 

Acceptable

- Packing material (EN 868)

- Process validated as per Doc #

 

- Product tested as per Doc #

 

 

 

 

10. Toxicity

Toxicity

 

 

 

 

 

Not acceptable

1. Material selection

2. Material testing prior to use

3. Testing of finished product

 

 

 

 

 

Acceptable

 

 

 

 

 

 

 

 

 

 

Related material specification

 

 

 

Material test procedure Doc. #

 

Risk Level: - 1. Nil        2. Very Low (Negligible)                  3. Low        4. High

 

 

RISK ANALYSIS REPORT

PRODUCT: - STERILE SINGLE USE INTRAVENOUS CANNULA                                                PRODUCT FAMILY:

 

Potential   Hazard

Description of specific hazards which may arise

Initial Risk Estimate

Mitigation Steps

Residuals risk After Mitigation

Comments, Test reports or References

 

 

1

2

3

4

Risk Status

 

1

2

3

4

Risk Status

 

11. Bio burden / Pre packing contamination

 

Pyrogenicity

 

 

 

 

 

 

Not acceptable

 

 

 

 

 

 

1. Process control

2. Testing

 

 

 

 

 

Acceptable

- Process control procedure

- Environment control & monitoring procedure Doc. #

- Pyrogenicity test procedure Doc. #

 

 

 

12. Sterilization process failure

Unsterile product

 

 

 

 

 

Not acceptable

1.      Sterilization process validation

2.      Sterilization process monitoring

3.      Sterility  testing

 

 

 

 

 

Acceptable

- ISO 11135 -1: Requirements for development, validation and routine control of a sterilization process for medical devices

-Sterilization process validation protocol Doc. #

- Related process specification Doc. #

 

- Sterility test procedure Doc. #

 

Risk Level: - 1. Nil        2. Very Low (Negligible)                  3. Low        4. High

RISK ANALYSIS REPORT

PRODUCT: - STERILE SINGLE USE INTRAVENOUS CANNULA                                                PRODUCT FAMILY:

 

Potential   Hazard

Description of specific hazards which may arise

Initial Risk Estimate

Mitigation Steps

Residuals risk After Mitigation

Comments, Test reports or References

 

 

1

2

3

4

Risk Status

 

1

2

3

4

Risk Status

 

13. MIXING OF DEFECTIVE MATERIAL WITH ACCEPTED MATERIAL

- Defective material reaches to user

- Injury or loss

 

 

 

Not acceptable

1.   Product identification & segregation

2.   Disposition of non-conformed material

3.   Verification

 

 

 

Acceptable

- Inspection & test status doc. #

- Control of non-conforming material doc. #

14. Ethylene oxide residuals

Toxic effects on the subject

 

 

 

 

 

Not acceptable

1. Sterilization cycle validation

2. Quarantine period

3.  E.O. residuals tests

 

 

 

 

 

 

Acceptable

- ISO 11135 -1: Requirements for development, validation and routine control of a sterilization process for medical devices validation process Doc. #

- E.O. residuals test procedure

15. Incompatibility with the device used in combination

1.      Loose connection

2.      Leakage

 

 

 

 

 

 

Not acceptable

1.      Standard Luer taper as per ISO 594-1

2.      Verification of luer taper

3.      Study with

combination 

     device

 

 

 

 

 

Acceptable

- ISO 594-1

- Compatibility study reports

 

Risk Level: - 1. Nil        2. Very Low (Negligible)                  3. Low        4. High

 

 

RISK ANALYSIS REPORT

PRODUCT: - STERILE SINGLE USE INTRAVENOUS CANNULA                                                PRODUCT FAMILY:

 

Potential   Hazard

Description of specific hazards which may arise

Initial Risk Estimate

Mitigation Steps

Residuals risk After Mitigation

Comments, Test reports or References

 

 

1

2

3

4

Risk Status

 

1

2

3

4

Risk Status

 

16. Improper product handling & storage

 

 

 

 

 

 

 

Packing and product damage / deterioration

 

 

 

 

 

Not acceptable

1.      Packaging design

2.      Material handling & storage procedure

3.      Material handling & storage instructions

 

 

 

 

 

Acceptable

Material preservation procedure Doc. #

17. Improper use of device

-    Local infection

-    Vein cross perforation

-    Peel back effect

 

 

 

 

 

 

Not acceptable

1.      Product design

2.      Instruction for use

 

 

 

 

 

 

Acceptable

-          Product design & development procedure Doc. #

 

       - Instruction for use

 

 

 

Risk Level: - 1. Nil        2. Very Low (Negligible)                  3. Low        4. High

 

 

UPDATED ON:

 

 

Copyrights 2009. Association of Indian Medical Device Industry.