FDA Adverse Event
Other
Summary report: N
IN-ROOM SHARPSTAR SHARPS DISPOSAL CONTAINER
MDR report key: 55318
·
Received September 25, 1996
Report
- Report Number
- 1419181-1996-00049
- Event Type
- Other
- Date Received
- September 25, 1996
- Date of Event
- July 27, 1996
- Manufacturer
- SAGE PRODUCTS, INC.
- Product Code
- MMK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTERS DESCRIPTION OF EVENT GIVEN VIA TELEPHONE ON 8/26/96 AND DURING ONSITE VISIT ON 9/10/96 RELAYED EVENT AS FOLLOWS: RN PLACED SUBCUTANEOUS NEEDLE/SYRINGE USED FOR A HEPARIN INJECTION INTO LID/DOOR AND "FLIPPED THE LID/DOOR", REPORTEDLY SOMEHOW THE SUBCUTANEOUS NEEDLE/SYRINGE TUMBLED OUT AND THE RN RECEIVED A NEEDLESTICK. ADD'L INFO RELAYED BY EMPLOYEE HEALTH NURSE TO MFR REP ON 8/27/96 DESCRIBED THE FOLLOWING DETAILS OF THE EVENT: THE RN DID NOT PLACE THE NEEDLE/SYRINGE COMPLETELY INTO THE OPENING OF THE DISPOSAL CONTAINER. WHEN SHE LIFTED THE DOOR FOR DISPOSAL THE PORTION OUTSIDE THE DOOR DID NOT ALLOW THE NEEDLE TO DROP DOWN AND IN SOME FASHION, SHE SUBSEQUENTLY RECEIVED A NEEDLESTICK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IN-ROOM SHARPSTAR SHARPS DISPOSAL CONTAINER | SHARPS DISPOSAL CONTAINER | MMK | SAGE PRODUCTS, INC. | 8509 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |