FDA Adverse Event
Malfunction
Summary report: N
3ML SYRINGE 20G X 1 RP
MDR report key: 8479494
·
Received April 3, 2019
Report
- Report Number
- 1017768-2019-00610
- Event Type
- Malfunction
- Date Received
- April 3, 2019
- Date of Event
- March 25, 2019
- Report Date
- April 3, 2019
- Manufacturer
- COVIDIEN
- Product Code
- FMF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. IF ADDITIONAL INFORMATION OR THE SAMPLE IS RECEIVED, THE INVESTIGATION WILL BE REOPENED AND RESPONDED TO ACCORDINGLY.
Description of Event or Problem · 1
THE CUSTOMER STATES: THE SYRINGES WERE LEAKING AROUND BLACK PLUNGER IN SYRINGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 272398 | 3ML SYRINGE 20G X 1 RP | SYRINGE, PISTON | FMF | COVIDIEN | 8881513033 | 832018 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |