FDA Adverse Event
Malfunction
Summary report: N
5 QT SHARPS CONTAINER
MDR report key: 2123630
·
Received June 10, 2011
Report
- Report Number
- 1424643-2011-00003
- Event Type
- Malfunction
- Date Received
- June 10, 2011
- Report Date
- June 6, 2011
- Manufacturer
- COVIDIEN
- Product Code
- MMK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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 THEY BELIEVE THERE WAS A DESIGN CHANGE TO THE LID AND THAT THE LID IS NOT CLOSING PROPERLY. THE CUSTOMER REPORTS THAT THE NEEDLE IS NOT FALLING INTO THE CONTAINER PROPERLY RESULTING IN A DIRTY NEEDLE STICK. CUSTOMER REPORTS THAT THE HOSP PROTOCOL WAS FOLLOWED FOR THIS EMPLOYEE. THE EMPLOYEE WAS SENT TO THE ER. THE EMPLOYEE WILL RECEIVE F/U IN 6 MONTHS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 5 QT SHARPS CONTAINER | SHARPS CONTAINER | MMK | COVIDIEN | 31144010 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |