FDA Adverse Event
Injury
Summary report: N
25-0101 ST NEEDLE CTR DBL MAG 20CT 1PK
MDR report key: 297282
·
Received September 20, 2000
Report
- Report Number
- 1046367-2000-00031
- Event Type
- Injury
- Date Received
- September 20, 2000
- Date of Event
- April 16, 2000
- Report Date
- September 15, 2000
- Manufacturer
- DEROYAL
- Product Code
- MMK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
NEEDLE STICK. UPON COMPLETION OF PROCEDURE, CLEANING UP BACK TABLE, NEEDLE COUNTER WAS CLOSED. NEEDLES SLIPPED OUT WHEN SNAPPING COUNTER TOGETHER-HINGE ON NEEDLE COUNTER NOT WORKING CAUSING NEEDLES TO "POP" OUT. LOT NUMBERS GIVEN ARE: 199779, 206385, AND 210358.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 25-0101 ST NEEDLE CTR DBL MAG 20CT 1PK | 4B4 NEEDLE COUNTERS | MMK | DEROYAL | * | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Life Threatening |