FDA Adverse Event
Other
Summary report: N
5ML, K3 EDTA, LAVENDER-HEMOGARD TUBE
MDR report key: 297048
·
Received September 21, 2000
Report
- Report Number
- 1917413-2000-00020
- Event Type
- Other
- Date Received
- September 21, 2000
- Date of Event
- August 30, 2000
- Report Date
- September 21, 2000
- Manufacturer
- BECTON DICKINSON & CO.
- Product Code
- JKA
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
TUBE WAS BEING FILLED VIA ROUTINE VENIPUNCTURE. WHEN TECH WENT TO REMOVE CAP TO RUN SAMPLE, TUBE BROKE AND CUT TECH ON LEFT THUMB. TECH WAS TESTED FOR BASELINE HIV AND HEPATITIS. BODY FLUIDS UNKNOWN AS BEING INFECTIOUS. REVIEW OF DATABASE INDICATES NO OTHER ISSUES WITH REGARD TO THIS PRODUCTION LOT NUMBER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 5ML, K3 EDTA, LAVENDER-HEMOGARD TUBE | EDTA TUBE | JKA | BECTON DICKINSON & CO. | NA | 0101895 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |