FDA Adverse Event
Malfunction
Summary report: N
HYDROLINE PULSEWAVE SYSTEM
MDR report key: 3254045
·
Received June 25, 2013
Report
- Report Number
- 3254045
- Event Type
- Malfunction
- Date Received
- June 25, 2013
- Date of Event
- June 7, 2013
- Report Date
- June 25, 2013
- Manufacturer
- CARDINAL HEALTH 200, INC.
- Product Code
- GBX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MA, US
Narratives
Description of Event or Problem · 1
HYDROLINE TRUMPET VALVE WITH PULSE WAVE CASSETTE (DISPOSABLE SUCTION/IRRIGATION DEVICE USED ON LAPAROSCOPIC CASES) WAS NOTED TO BE SPRAYING A FINE MIST FROM THE UNUSED SPIKE END. THE CLAMP WAS NOTED TO BE FULLY CLOSED. A PINHOLE WAS NOTED IN THE SPIKE PROTECTIVE CAP. THE TUBING HAD TO BE FOLDED ON ITSELF(PINCHED) AND A METAL SURGICAL CLAMP APPLIED TO STOP THE LEAK. THIS ITEM HAS BEEN FLUSHED AND SEQUESTERED.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 288081 | HYDROLINE PULSEWAVE SYSTEM | IRRIGATION, SUCTION, SYSTEM | GBX | CARDINAL HEALTH 200, INC. | * | 00000529750 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |