FDA Adverse Event
Malfunction
Summary report: N
SYRINGE - 60CC LUER LOCK
MDR report key: 5986602
·
Received September 27, 2016
Report
- Report Number
- MW5065084
- Event Type
- Malfunction
- Date Received
- September 27, 2016
- Date of Event
- February 19, 2015
- Report Date
- September 27, 2016
- Manufacturer
- INTERNATIONAL MEDISURG CONNECTION INC.
- Product Code
- FMF
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
THE SYRINGE HAD A CRACK RESULTING IN THE RESIDENT GETTING SPLASHED IN THE FACE WHILE CONDUCTING A BEDSIDE PARACENTESIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 632137 | SYRINGE - 60CC LUER LOCK | SYRINGE - 60CC LUER LOCK | FMF | INTERNATIONAL MEDISURG CONNECTION INC. | 13-7818-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |