FDA Adverse Event
Malfunction
Summary report: N
19 FRENCH ROUND FLUTED JP DRAIN
MDR report key: 18096732
·
Received November 7, 2023
Report
- Report Number
- MW5147937
- Event Type
- Malfunction
- Date Received
- November 7, 2023
- Date of Event
- September 29, 2023
- Report Date
- October 24, 2023
- Manufacturer
- C.R. BARD, INC.
- Product Code
- GBX
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
BARD MEDICAL 19 FRENCH FLUTED SILICON JP DRAIN, PART #072190, BROKE OFF DURING ATTEMPTED REMOVAL AND SILICON TIP OF DRAIN WAS RETAINED INSIDE THE PATIENT. POSSIBLE LOT #S: NGGN2906, NGGZ2612, NGGV0936.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1805364 | 19 FRENCH ROUND FLUTED JP DRAIN | CATHETER, IRRIGATION | GBX | C.R. BARD, INC. | NGGN2906 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Female | Other |