FDA Adverse Event
Malfunction
Summary report: Y
ULTRACLAMP TUBING CLAMP
MDR report key: 8291323
·
Received January 30, 2019
Report
- Report Number
- 1416980-2019-00426
- Event Type
- Malfunction
- Date Received
- January 30, 2019
- Report Date
- January 30, 2019
- Manufacturer
- BAXTER HEALTHCARE - CLEVELAND
- Product Code
- FKK
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THIS REPORT SUMMARIZES ONE MALFUNCTION EVENTS. IT WAS REPORTED THAT AN ULTRACLAMP TUBING CLAMP CAME LOOSE, LEADING TO A LEAK OF SOLUTION. THIS EVENT INVOLVED A PATIENT WITH NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 81156 | ULTRACLAMP TUBING CLAMP | CLAMP, LINE | FKK | BAXTER HEALTHCARE - CLEVELAND | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |