FDA Adverse Event
Malfunction
Summary report: N
ULTRACLAMP TUBING CLAMP
MDR report key: 3595052
·
Received January 28, 2014
Report
- Report Number
- 1416980-2014-02754
- Event Type
- Malfunction
- Date Received
- January 28, 2014
- Date of Event
- January 6, 2014
- Report Date
- January 7, 2014
- Manufacturer
- BAXTER HEALTHCARE - CLEVELAND
- Product Code
- FKK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, AN EVALUATION COULD NOT BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ULTRA CLAMP DID ¿NOT HOLD WELL.¿ THE REPORTER STATED THAT A DRAINAGE BAG LEAKED WHEN CLAMPED WITH THE DEVICE. IT WAS NOT SPECIFIED WHEN IN THE PROCESS THIS OCCURRED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 61506 | ULTRACLAMP TUBING CLAMP | CLAMP, LINE | FKK | BAXTER HEALTHCARE - CLEVELAND |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CYCLER DRAINAGE SET (5C4145P) |