FDA Adverse Event
Malfunction
Summary report: N
MICROCLACE MED INC - HOSPIRA
MDR report key: 1783012
·
Received July 23, 2010
Report
- Report Number
- MW5016915
- Event Type
- Malfunction
- Date Received
- July 23, 2010
- Date of Event
- July 22, 2010
- Report Date
- July 23, 2010
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NE, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
ON THE SURGICAL FLOOR THE NURSE WAS ROUNDING ON A PT AND SAW THAT THE PT WAS BLEEDING FROM HIS IV. THE LUER LOCK CONNECTING SITE BY THE BLUE PORT OF AN IV EXTENSION SET CLAVE WAS DISCONNECTED FROM THE TUBING. THERE WAS NO COMPLICATION TO THE PT. THE IV WAS DC'D WITHOUT INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICROCLACE MED INC - HOSPIRA | IV EXTENSION WITH CLAVE | FPA | 12551 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR |