FDA Adverse Event
Malfunction
Summary report: N
BECKTON-DICKINSON SYRINGE
MDR report key: 185404
·
Received August 31, 1998
Report
- Report Number
- 1317056-1998-00030
- Event Type
- Malfunction
- Date Received
- August 31, 1998
- Date of Event
- August 3, 1998
- Report Date
- August 3, 1998
- Manufacturer
- SCHNEIDER/NAMIC
- Product Code
- DXT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
END USER HOSPITAL REPORTED THAT WHILE PULLING BACK ON CONTROL SYRINGE ATTACHED TO THE MANIFOLD, AIR WAS PULLING IN AND CAUSING BUBBLES. THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BECKTON-DICKINSON SYRINGE | 20CC CONTROL SYRINGE | DXT | SCHNEIDER/NAMIC | NA | 179222 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |