FDA Adverse Event
Malfunction
Summary report: N
CURLIN ADMINISTRATION SET
MDR report key: 2061376
·
Received March 18, 2011
Report
- Report Number
- 1722139-2011-00034
- Event Type
- Malfunction
- Date Received
- March 18, 2011
- Date of Event
- February 14, 2011
- Report Date
- March 18, 2011
- Manufacturer
- MOOG MEDICAL DEVICES GROUP
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION PROVIDED IN THE COMPLAINT WAS UNCLEAR SO THE CUSTOMER E-MAIL (NO NUMBER PROVIDED) TO ASK FOR CLARIFICATION. THE COMPLAINT, AS REPORTED, APPEARS AS THOUGH THE PINCH CLAMP OCCLUDER BREAK AWAY TAB WAS NOT REMOVED. THE TAB, WHEN REMOVED, ALLOWS THE PINCH CLAMP TO ENGAGE OCCLUDING THE TUBING. DIRECTIONS FOR USE ARE TO REMOVE THE BREAKAWAY TAB BEFORE PRIMING. A FOLLOW UP WILL BE SUBMITTED WHEN A RESPONSE FROM THE NURSE IS RECEIVED.
Description of Event or Problem · 1
COMPLAINT STATES THAT THE SET LEAKED. LIQUID HAS GONE STRAIGHT THROUGH AS THOUGH NOT CLAMPED. DURING PRIMING LIQUID WENT THROUGH IN MINUTES NOT SECONDS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURLIN ADMINISTRATION SET | FRN | MOOG MEDICAL DEVICES GROUP | 340-4163 | D934103 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |