FDA Adverse Event
Malfunction
Summary report: N
SINGLE SHOT
MDR report key: 2935958
·
Received January 28, 2013
Report
- Report Number
- 2935958
- Event Type
- Malfunction
- Date Received
- January 28, 2013
- Date of Event
- January 7, 2013
- Report Date
- January 18, 2013
- Manufacturer
- KIMBERLY CLARK CORP.
- Product Code
- CAZ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- WI, US
Narratives
Description of Event or Problem · 1
EPIDURAL INJECTION TRAY WAS OPENED WHILE SETTING UP FOR THE PROCEDURE AND IT WAS NOTED THAT THE 10 ML AMPULE CONTAINING NACL WAS BROKEN. THERE WAS NO FLUID IN THE AMPULE OR THE TRAY. GLASS SHARDS CAN BE SEEN IN THE TRAY. THIS TYPE OF EVENT HAS NOT BEEN REPORTED IN THE PAST. TRAYS ARE RECEIVED IN MATERIALS MANAGEMENT AND TRANSPORTED TO THE CLEAN SUPPLY ROOM IN THE DEPARTMENT WHERE THEY ARE STORED UNTIL USED. NO OUTWARD EVIDENCE THAT THE PACKAGE HAD BEEN DAMAGED IN ANY WAY. NO PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 38048 | SINGLE SHOT | TRAY, EPIDURAL | CAZ | KIMBERLY CLARK CORP. | * | 0200732433 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |