FDA Adverse Event
Malfunction
Summary report: N
CARDINAL HEALTH, -6- SPONGE LAP 18X18 XRAY 5 / PACK
MDR report key: 2163518
·
Received July 8, 2011
Report
- Report Number
- MW5021299
- Event Type
- Malfunction
- Date Received
- July 8, 2011
- Report Date
- July 8, 2011
- Product Code
- GDY
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- KY, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
SINCE (B)(6) 2011, OUR OB TECH HAS NOTED A DISCOLORATION OF FLUID IN THE OPERATING ROOM BASIN AFTER PLACING LAPS IN THE BASIN AND POURING ON STERILE SALINE. THE DISCOLORATION OF THE FLUID IS ONLY NOTED WITH A SPECIFIC BATCH OF LAP SPONGES, THESE ARE BANDED WITH A "CHINA 99" BAND. THE DISCOLORATION RAGES FROM A MURKEY CLOUDY COLORATION TO DARK, TEA COLORED LIQUID. IT IS NOT CONSISTENT IN THE DISCOLORATION OF THE LAPS WITH THIS BAND. THE MFR OF THE PRODUCT CARDINAL HEALTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARDINAL HEALTH, -6- SPONGE LAP 18X18 XRAY 5 / PACK | C/S CUSTOM PACK, BANDED WITH "CHINA 99" | GDY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |