FDA Adverse Event
Malfunction
Summary report: N
BD DIALYSIS/HD CATHETER
MDR report key: 15785054
·
Received November 11, 2022
Report
- Report Number
- 3006260740-2022-05081
- Event Type
- Malfunction
- Date Received
- November 11, 2022
- Date of Event
- September 14, 2020
- Report Date
- October 21, 2022
- Manufacturer
- C.R. BARD, INC. (BASD) -3006260740
- Product Code
- NIE
- PMA / PMN Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE DATE OF EVENT WAS NOT PROVIDED BY THE COMPLAINANT/REPORTER, THE DATE REFLECTED IN THIS REPORT IS THE DATE BD BECAME AWARE OF THE EVENT. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.
Description of Event or Problem · 0
IT WAS REPORTED DURING CLINICAL ASSESSMENT FLUID LEAKING FROM CENTRAL LINE INSERTION SITE. THE EVENT INVOLVED 2 TL DIALYSIS INSERTED IN THE NECK. THIS REPORT ADDRESSES THE FIRST DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2757608 | BD DIALYSIS/HD CATHETER | CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED | NIE | C.R. BARD, INC. (BASD) -3006260740 | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |