BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM
Report
- Report Number
- 3006948883-2025-00091
- Event Type
- Malfunction
- Date Received
- April 22, 2025
- Date of Event
- February 13, 2025
- Report Date
- June 13, 2025
- Manufacturer
- BD SUZHOU (MDS)
- Product Code
- FOZ
- UDI-DI
- 00382903830121
- PMA / PMN Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
1. NO DEFECTIVE SAMPLE AND PHOTO HAVE BEEN RECEIVED FOR THE COMPLAINT. 2. DHR/BHR REVIEW (LOT#4233035): 1) THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN SEP 2024 AND PACKAGED AT CFS PACKAGE LINE IN SEP 2024. WORK ORDER QUANTITY WAS (B)(4) EA. 2) REVIEW THE IN-PROCESS TEST REPORTS AND OUTGOING TEST REPORTS, AND ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS. 3) REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR 45PSI LEAKAGE TEST, THE SAMPLE TEST IS QUALIFIED, NO LEAKAGE IS FOUND. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. BECAUSE THE SPECIFIC LEAKAGE SITE AND ABNORMAL STATE OF THE DEFECTIVE SAMPLE CANNOT BE IDENTIFIED, SO THE ROOT CAUSE OF LEAKAGE CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TRACKING THE ISSUE.
A PHOTO OF THE AFFECTED UNIT WAS RECEIVED AFTER THE SUBMISSION OF THE MDR SUPPLEMENTAL #1. THIS MDR SUPPLEMENTAL #2 CAPTURES EVALUATION OF THE PHOTO RECEIVED AND THE INVESTIGATION CONCLUSION. INVESTIGATION SUMMARY: 1. THE CUSTOMER RETURNED 1 PHOTO, BUT DID NOT RETURN THE DEFECTIVE SAMPLES. THE PHOTO SHOWED THAT THE GAUGE OF THE SAMPLE WAS 20GA AND BLOOD OOZING FROM THE END OF THE SEPTUM. 2. PRODUCTION RECORD CHECK (LOT#4233035): 1) THIS BATCH OF PRODUCTS WILL BE ASSEMBLED IN JINGMA AUTOMATIC LINE 4 IN SEPTEMBER 2024 AND PACKAGED IN CFS AND R240 PACKAGING LINE IN SEPTEMBER 2024. THE NUMBER OF WORK ORDERS IS 99,000 PIECES. 2) ISOLATED PLUG INCOMING INSPECTION, NO ABNORMAL APPEARANCE AND SIZE, IN LINE WITH THE REQUIREMENTS OF INCOMING INSPECTION SPECIFICATIONS. 3) 400 LEAKAGE TESTS IN PROCESS TESTING AND 32 LEAKAGE TESTS IN SHIPMENT TESTING, THE TEST RESULTS ARE IN LINE WITH PRODUCT STANDARDS. 4) THERE ARE NO NON-CONFORMITIES, DEVIATIONS OR REWORK DURING THE PRODUCTION PROCESS. 5) ISOLATION PLUG ASSEMBLY EQUIPMENT WITHOUT ABNORMAL MAINTENANCE. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR 45PSI LEAKAGE TEST, THE SAMPLE TEST IS QUALIFIED, NO LEAKAGE IS FOUND. CONCLUSION(S): THE RETURNED PHOTO SHOWED BLOOD OOZING FROM THE END OF THE SEPTUM. NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE. BECAUSE NO DEFECTIVE SAMPLE WAS RECEIVED FOR FURTHER TESTING, SO THE ROOT CAUSE OF LEAKAGE CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TRACKING THE ISSUE.
IT WAS REPORTED THAT BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM LEAKED.
NO ADDITIONAL INFORMATION IS AVAILABLE.
NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1123957 | BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM | INTRAVASCULAR CATHETER | FOZ | BD SUZHOU (MDS) | 4233035 | 00382903830121 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |