FDA Adverse Event
Malfunction
Summary report: N
MICROTAINER BRAND QUIK-HEEL LANCET (INFANT)
MDR report key: 235755
·
Received August 5, 1999
Report
- Report Number
- 2648228-1999-00001
- Event Type
- Malfunction
- Date Received
- August 5, 1999
- Report Date
- August 4, 1999
- Manufacturer
- BECTON DICKINSON VACUTAINER SYS. MICROPETTE, INC.
- Product Code
- FMK
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
LANCET DID NOT RETRACT AND NURSE DOING PKU TEST ON A NEWBORN INFANT PUT LANCET DOWN, PICKED UP AND STUCK HERSELF BECAUSE LANCET DID NOT RETRACT. PRODUCT SAMPLE IN QUESTION NOT AVAILABLE. PRODUCT WAS DISPOSED OF IN BIOHAZARD CONTAINER. NURSE FOLLOWED HOSPITAL PROCEDURE FOR BLOOD EXPOSURE, TESTED FOR HIV AND HEP. (RESULTS CONFIDENTIAL) WOUND WAS SMALL, SMALL PUNCTURE, CLEANSED, REQUIRING NO STITCHES OR DRESSING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICROTAINER BRAND QUIK-HEEL LANCET (INFANT) | LANCET | FMK | BECTON DICKINSON VACUTAINER SYS. MICROPETTE, INC. | NA | 8E400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |