BD UNKNOWN PIVC
Report
- Report Number
- 3002601200-2024-00364
- Event Type
- Malfunction
- Date Received
- July 31, 2024
- Date of Event
- June 23, 2024
- Report Date
- August 13, 2024
- Manufacturer
- BD SUZHOU (MDS)
- Product Code
- ONB
- UDI-DI
- 00382903830992
- PMA / PMN Number
- K123213
- 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.
IN RESPONSE TO THE EVENT REPORTED BY YOUR FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 4033159. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS.
IT WAS REPORTED THAT BD UNKNOWN PIVC LEAKED THE PATIENT WITH "COLITIS, DIZZINESS, AND SHOCK" WAS ADMITTED AND GIVEN AN INDWELLING NEEDLE FOR INFUSION. DURING THE INFUSION, IT WAS FOUND THAT THE INDWELLING NEEDLE WAS LEAKING. THE HEPARIN CAP WAS REPLACED. IF THERE WAS STILL LEAKAGE, THE INDWELLING NEEDLE WAS REPLACED.
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 517601 | BD UNKNOWN PIVC | INTRAVASCULAR CATHETER | ONB | BD SUZHOU (MDS) | 4033159 | 00382903830992 | |
| 912187 | BD UNKNOWN PIVC | INTRAVASCULAR CATHETER | ONB | BD SUZHOU (MDS) | 4033159 | 00382903830992 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |