FDA Adverse Event
Other
Summary report: N
PAB IV CONTAINER BAG
MDR report key: 6202085
·
Received December 22, 2016
Report
- Report Number
- MW5066878
- Event Type
- Other
- Date Received
- December 22, 2016
- Report Date
- November 2, 2016
- Manufacturer
- B. BRAUN
- Product Code
- KPE
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
B. BRAUN HAS JUST RECENTLY STARTED PLACING THE BARCODE FOR THEIR PAB IV CONTAINER BAGS RIGHT IN THE CENTER OF THE BAG (INSTEAD OF WHERE IT WAS PREVIOUSLY AT ON THE TOP OF THE BAG) WHERE IT'S BEING COVERED, WHEN IN ITS OVERWRAP, BY THE BAG SEAL. THE BAG SEAL IS A GIANT CREASE DOWN THE CENTER OF THE BAG OBSTRUCTING THE ABILITY TO BARCODE SCAN THE PRODUCT. THIS IMPEDES THE ABILITY OF NURSES AND PHARMACY STAFF FROM ACCURATELY BARCODE SCANNING THE BAG WHEN USING WITH IV WORK/FLOW SOFTWARE, BEING DISPENSED FROM AN AUTOMATED DISPENSING MACHINE, OR DISPENSING FROM CENTRAL PHARMACY AUTOMATION EQUIPMENT. IN CONTACTED B. BRAUN AND THIS IS A PERMANENT SWITCH IN THE PLACEMENT OF THEIR BARCODE ON THEIR PAB IV CONTAINER BAGS. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 849315 | PAB IV CONTAINER BAG | IV, CONTAINER | KPE | B. BRAUN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |