FDA Adverse Event
Malfunction
Summary report: N
2 GA SHARPSTAR - TRANS. RED
MDR report key: 8131152
·
Received December 4, 2018
Report
- Report Number
- 1424643-2018-00514
- Event Type
- Malfunction
- Date Received
- December 4, 2018
- Date of Event
- November 13, 2018
- Report Date
- December 4, 2018
- Manufacturer
- COVIDIEN
- Product Code
- MMK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MANSFIELD PRODUCT MONITORING HAS ATTEMPTED TO GATHER ADDITIONAL DETAILS OF THE EVENT AND PRODUCT INVOLVED HOWEVER NO FURTHER DETAILS HAVE BEEN RECEIVED AT THE TIME OF THIS REPORT. THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
CUSTOMER REPORTS THAT TWO CONTAINER/LIDS WERE CRACKED OR BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 971160 | 2 GA SHARPSTAR - TRANS. RED | CONTAINER, SHARPS | MMK | COVIDIEN | 8534SA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |