BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN ADMINISTRATION SET

    MDR report key: 1983119 · Received February 1, 2011

    Report

    Report Number
    1722139-2011-00019
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    December 15, 2011
    Report Date
    February 1, 2011
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A UNUSED SAMPLE WAS RECEIVED ON (B)(4) 2010 AND THE SAMPLE WAS PRIMED SUCCESSFULLY, THE SET OCCLUDED AS INTENDED, AND THE SET DID NOT LEAK. THE INFO PROVIDED IN THE COMPLAINT WAS UNCLEAR SO THE CUSTOMER WAS CALLED ON (B)(4) 2011 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. THE CUSTOMER DID STATE THAT THE DEVICES ARE RELATIVELY NEW AT THEIR FACILITY AND THIS IS A POSSIBILITY BUT THE NURSE WOULD NEED TO BE CONTACTED FOR CLARIFICATION. QUESTIONS WERE PROVIDED BY (B)(4) TO THE CUSTOMER TO RELAY TO THE NURSE. 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