FDA Adverse Event
Malfunction
Summary report: N
HEMAQUET EXCEL
MDR report key: 36852
·
Received August 29, 1996
Report
- Report Number
- 1217435-1996-00009
- Event Type
- Malfunction
- Date Received
- August 29, 1996
- Report Date
- August 1, 1996
- Manufacturer
- USCI DIV. C.R. BARD, INC.
- Product Code
- DYB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING A DIAGNOSTIC PROCEDURE, THE VALVE OF THIS DEVICE LEAKED. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE AND THE DEVICE IS BEING RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEMAQUET EXCEL | CATHETER INTRODUCER | DYB | USCI DIV. C.R. BARD, INC. | NA | 11KF0605 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |