BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN ADMINISTRATION SET

    MDR report key: 3944295 · Received May 8, 2014

    Report

    Report Number
    1722139-2014-00107
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 5, 2014
    Report Date
    April 7, 2014
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED ADMINISTRATION SET WITHOUT THE OUTER PACKAGING, TO VERIFY THE LOT NUMBER, WAS RETURNED TO (B)(4) MOOG FOR EVALUATION. THE ADMINISTRATION SET WAS MANUALLY PRIMED WITH WATER AND LEAKAGE WAS FOUND ALONG THE EDGE OF FILTER.

    Description of Event or Problem · 1

    PATIENT STATED THAT THE ADMINISTRATION SET IS LEAKING AT THE FILTER. INTERMITTENT THERAPY WAS USED AT RATE 195 ML/HR. THE BAG VOLUME WAS 1 LITER. THERE WAS NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278018 CURLIN ADMINISTRATION SET FRN MOOG MEDICAL DEVICES GROUP 340-4128

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR NAFCILLIN