FDA Adverse Event
Malfunction
Summary report: N
VHA PLUS SHRPS 2GL RED ANCIL20
MDR report key: 2222389
·
Received July 15, 2011
Report
- Report Number
- 1424643-2011-00004
- Event Type
- Malfunction
- Date Received
- July 15, 2011
- Date of Event
- July 11, 2011
- Report Date
- July 14, 2011
- Manufacturer
- COVIDIEN
- Product Code
- MMK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(6) 2011. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2011 THAT A CUSTOMER HAD AN ISSUE WITH A SHARPS CONTAINER. THE CUSTOMER REPORTS THAT THERE WAS A NEEDLE PROTRUDING FROM THE BOTTOM OF THE CONTAINER, AND WHEN THE EMPLOYEE WENT TO CHANGE THE CONTAINER WITH A NEW ONE, THEY RECEIVED A DIRTY NEEDLE STICK/CUT. IN RESPONSE, THE EMPLOYEE HAD BLOOD WORK DONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VHA PLUS SHRPS 2GL RED ANCIL20 | SHARPS CONTAINER | MMK | COVIDIEN | V8970 | 20-08407-101170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |