FDA Adverse Event
Malfunction
Summary report: N
ARROW CATHETER
MDR report key: 54774
·
Received July 29, 1996
Report
- Report Number
- 54774
- Event Type
- Malfunction
- Date Received
- July 29, 1996
- Date of Event
- January 17, 1996
- Report Date
- January 30, 1996
- Manufacturer
- ARROW INTL.
- Product Code
- GBZ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
WHILE DOING LAPAROSCOPIC CHOLECYSTECTOMY, SHEATH FROM CATHETER CAME OFF AND FELL IN PT'S ABDOMEN. DR WAS ABLE TO RETRIEVE IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARROW CATHETER | CHOLANGIOGRAM CATHETER | GBZ | ARROW INTL. | CS-01700 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |