FDA Adverse Event
Summary report: N
MONOJECT NEEDLE
MDR report key: 36130
·
Received August 20, 1996
Report
- Report Number
- MW4001452
- Date Received
- August 20, 1996
- Report Date
- August 15, 1996
- Manufacturer
- SHERWOOD MEDICAL CO.
- Product Code
- FMI
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A BLOOD STAIN WAS FOUND IN 7 NEWLY OPENED NEEDLES PRIOR TO USE BY THE CLINICAL LABORATORY TECHINICIAN ON TWO SEPARATE DAYS. A REDDISH STAIN WAS IDENTIFIED ON THE SLEEVES OF THE NEEDLE PORTION THAT IS USED TO PENETRATE THE RUBBER CAP OF THE BLOOD COLLECTION TUBE. A SAMPLE OF THIS MATERIAL WAS PREPARED ON A NORMAL SALINE WETMOUNT SLIDE AND RED BLOOD CELLS WERE IDENTIFIED. ALL NEEDLES FROM THIS MFR WERE IMMEDIATELY PULLED FROM THE LAB AND WILL BE STORED AS A BIOHAZARDOUS WASTE UNTIL FURTHER NOTICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MONOJECT NEEDLE | NEEDLE | FMI | SHERWOOD MEDICAL CO. | 22 GA | 236040 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |