FDA Adverse Event
Malfunction
Summary report: N
LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
MDR report key: 6965930
·
Received October 20, 2017
Report
- Report Number
- 3009889060-2017-00001
- Event Type
- Malfunction
- Date Received
- October 20, 2017
- Date of Event
- May 8, 2017
- Report Date
- September 5, 2017
- Manufacturer
- BEILUN PLASTECH, INC
- Product Code
- GBZ
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PROCEDURE, BEFORE THE DEVICE WAS IN USE, THE TIP THAT CONNECTS THE TUBING TO THE FEMALE LUER FITTING BROKE OFF. SPECIFICALLY, THE FEMALE LUER FITTING BROKE AT THE BASE OF THE CONNECTION TO THE CATHETER TUBE. NO INTERVENTION WAS REQUIRED SINCE THE ISSUE WAS DISCOVERED BEFORE THE DEVICE WAS USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 743668 | LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER | CHOLANGIOGRAPHY CATHETER | GBZ | BEILUN PLASTECH, INC | PMIXL11 | 8170101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |