FDA Adverse Event
Other
Summary report: N
3 GA SHARPSTAR II CONT CLR 10
MDR report key: 353666
·
Received September 25, 2001
Report
- Report Number
- 1424643-2001-00017
- Event Type
- Other
- Date Received
- September 25, 2001
- Date of Event
- August 5, 2001
- Report Date
- August 31, 2001
- Manufacturer
- THE KENDAL COMPANY
- Product Code
- MMK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO KENDALL THAT A NURSE WAS STUCK PUTTING A BUTTERFLY INTO A SHARPS CONTAINER. THEY ARE USING THE BD SAFETY LOK BUTTERFLY, SALES REP ASKED HOW NEEDLESTICK OCCURRED WITH A SAFETY BUTTERFLY - DID THEY NOT ACTIVIATE IT? SALES PERSON IS RE-INSERVICING ACCOUNT DUE TO PROBABLE USER ERROR IN THIS AND OTHER POSSIBLE INCIDENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 43625 | 3 GA SHARPSTAR II CONT CLR 10 | SHARPS CONTAINER | MMK | THE KENDAL COMPANY | * | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |