BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC
Report
- Report Number
- 3002601200-2024-00572
- Event Type
- Malfunction
- Date Received
- November 1, 2024
- Date of Event
- September 28, 2024
- Report Date
- November 13, 2024
- Manufacturer
- BD SUZHOU (MDS)
- Product Code
- FOZ
- UDI-DI
- 00382903830831
- PMA / PMN Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
1. DHR/BHR REVIEW LOT#4081459. 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN APRIL 2024, AND PACKAGED AT R240 PACKAGE LINE AND CFS PACKAGE LINE IN APRIL 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. 2. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED, AND THE SPECIFIC SITE AND STATES OF THE CATHETER BREAKAGE CANNOT BE IDENTIFIED. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR THE RELEVANT FUNCTIONAL TESTS OF THE CATHETER: THE 45PSI LEAKAGE TEST AND THE PULL FORCE TEST OF THE CATHETER. THE TEST RESULTS SHOW THAT NO LEAKAGE IS FOUND AT THE CATHETER, AND THE PULL FORCE OF THE CATHETER IS WITHIN THE PRODUCT SPECIFICATIONS. PLEASE SEE THE ATTACHMENT FOR TEST REPORTS. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): SINCE NO ABNORMALITIES ARE FOUND IN THE PROCESS AND RETAINED SAMPLE, NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS, AND NO DEFECTIVE SAMPLE HAS BEEN RECEIVED FOR FURTHER INSPECTION, THE ROOT CAUSE OF THE CATHETER BREAKAGE CANNOT BE CONFIRMED.
IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC CATHETER BROKE / SEPARATED AFTER PLACEMENT PATIENT DEMENTIA, FOR THE FEMUR FRACTURE POSTOPERATIVE. ON (B)(6) 09:30 NURSE IN ACCORDANCE WITH MEDICAL ADVICE TO OPEN THE PACKAGING INTACT CLOSED INTRAVENOUS NEEDLE, GIVE THE PATIENT FOR THE NEEDLE PUNCTURE PAIN MEDICATION INFUSION, 11:00 THERE ARE MORE THAN THE END OF THE INFUSION. NURSE AT 12:00 ROUNDS FOUND THAT THE INDWELLING NEEDLE HAS BEEN REMOVED BY ITSELF, NO STUMP, IMMEDIATELY GIVE THE PATIENT COMPRESSION HEMOSTASIS, HAND LOCAL SUPERFICIAL ULTRASOUND, DID NOT SEE THE STUMP OF THE INDWELLING NEEDLE. THE SEARCH CONTINUED AND THE BROKEN END WAS FOUND AT THE BEDSIDE 15 MINUTES LATER. MEASURES: PATIENT WAS GIVEN COMPRESSION HEMOSTASIS, LOCALIZED SUPERFICIAL COLOR ULTRASOUND OF THE HAND, AND THE STUMP WAS FOUND AT THE BEDSIDE 15 MINUTES LATER. MEDICAL ADVICE WAS CHANGED TO INTRAMUSCULAR INJECTION AND ORAL PAIN MEDICATION. THERE WERE NO SERIOUS EFFECTS ON THE PATIENT.
NO ADDITIONAL INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2176261 | BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC | INTRAVASCULAR CATHETER | FOZ | BD SUZHOU (MDS) | 4081459 | 00382903830831 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |