1424643-2017-05005
Report
- Report Number
- 1424643-2017-05005
- Event Type
- Malfunction
- Date Received
- April 6, 2017
- Report Date
- March 9, 2017
- Manufacturer
- COV LP/LLC, CRYSTAL LAKE, MFG
- Product Code
- MMK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
SUBMIT DATE: 4/6/2017. AN INVESTIGATION IS CURRENTLY UNDER WAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED.
THE DEVICE HISTORY RECORDS DATA WAS REVIEWED FOR LOT # 173917 AND NO INTERNAL REJECTS WERE FOUND DURING PRODUCTION OF THE LOT. THE POTENTIAL ROOT CAUSE FOR THE REPORTED CONDITION IS CUSTOMER MISUSE. THE CONTAINER WAS FILLED ABOVE THE FILL LINE AS PER COMPLAINT DESCRIPTION. THERE IS A WARNING ON THE LABEL NOT TO OVER FILL WHICH WAS NOT FOLLOWED DURING USE. BASED ON THE EXISTING CONTROLS, THE INTERNAL REJECT AND THE COMPLAINT HISTORY REVIEW, NO FORMAL INVESTIGATION IS REQUIRED AT THIS TIME. THIS WILL BE USED FOR TRACKING AND TRENDING PURPOSES. THIS ISSUE HAS BEEN DETERMINED TO BE AN ISOLATED EVENT DUE TO CUSTOMER MISUSE. THE CONTAINER WAS FILLED ABOVE THE FILL LINE AS PER EVENT DESCRIPTION. THERE IS NO HARM OR INJURY REPORTED FOR THE COMPLAINT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
THE CUSTOMER REPORTS THAT THE SHARPS CONTAINER HAS BEEN PUNCTURED.
THE CUSTOMER REPORTS THAT THE SHARPS CONTAINER HAS BEEN PUNCTURED. (CUSTOMER MISUSE)-FROM (B)(4) THE CUSTOMER STATES; OF HEARING OF A SHARPS CONTAINER BEING PUNCTURED. IT'S CLEAR FROM THE WARNING ON THE LABEL NOT TO OVER FILL IT. THE CUSTOMER JUST WANTED TO MAKE SURE THE MANUFACTURER AND YOU ARE AWARE OF THIS IN CASE IT WOULD ISOLATED INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 248418 | MMK | COV LP/LLC, CRYSTAL LAKE, MFG | 065 | 00173917 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |