BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS-535-1

    MDR report key: 2945420 · Received February 1, 2013

    Report

    Report Number
    2245270-2013-00009
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    January 11, 2013
    Report Date
    February 1, 2013
    Manufacturer
    VYGON MANUFACTURING
    Product Code
    FPA
    PMA / PMN Number
    K021395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MALFUNCTION DEVICE WAS RETURNED TO VYGON US, AND WAS FORWARDED TO THE COMPONENT SUPPLIER (FEMALE LUER LOCK) FOR EVALUATION AND INVESTIGATION. THE RESULTS FOR THIS INVESTIGATION WILL BE SENT TO FDA IN A FOLLOW-UP MDR WITH IN THIRTY DAYS OF ITS' CONCLUSION.

    Description of Event or Problem · 1

    INFANT WAS CONNECTED TO A TRIFURCATED EXTENSION SET. THE FEMALE LUER ON ONE OF THE LINES CRACKED WHICH LED TO THE INFUSATE TO LEAK OUT. THE NURSE NOTICED THIS RIGHT AWAY AND REPLACED THE EXTENSION SET. THE INFANT EXPERIENCED NO HARM AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44734 AMS-535-1 6" TRIFURCATED EXTENSION SET FPA VYGON MANUFACTURING AMS-535-1 1208115

    Patients

    Seq Age Sex Outcome Treatment
    1