FDA Adverse Event
Malfunction
Summary report: N
BAC T ALERT AEROBIC CURO BOTTLE
MDR report key: 29974
·
Received February 8, 1996
Report
- Report Number
- MW1008300
- Event Type
- Malfunction
- Date Received
- February 8, 1996
- Date of Event
- February 3, 1996
- Report Date
- February 7, 1996
- Manufacturer
- ORGANON TEKNIKA CORP.
- Product Code
- JSC
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CO, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
RN DREW 1 CC OF BLOOD FOR BLOOD CULTURE. CHANGED NEEDLES TO ENSURE STERILE ENTRY INTO CULTURE TUBE. EXPELLED .5 CC OF BLOOD INTO CULTURE VIAL, THEN PRESSURE FROM TUBE CAUSED NEEDLE TO DETACH FROM SYRINGE CAUSING BLOOD TO SPLATTER OVER RN, COUNTERTOPS AND PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BAC T ALERT AEROBIC CURO BOTTLE | SPECIMEN TUBE | JSC | ORGANON TEKNIKA CORP. | 104647 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |