BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7 MICROBORE TRIFURCATED EXTENSION SET

    MDR report key: 3788630 · Received January 17, 2014

    Report

    Report Number
    2245270-2014-00006
    Event Type
    Malfunction
    Date Received
    January 17, 2014
    Date of Event
    December 8, 2013
    Report Date
    January 16, 2014
    Manufacturer
    VYGON CORP.
    Product Code
    FPA
    PMA / PMN Number
    K021395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MALFUNCTION OCCURRED FIVE TIMES FOR THIS CUSTOMER. PLEASE REFER TO THE MDRS LISTED BELOW FOR INFORMATION ON THE ADDITIONAL OCCURRENCES. 2245270-2014-00002, 2245270-2014-00003, 2245270-2014-00004, 2245270-2014-00005. THE TWO OF THE FIVE MALFUNCTIONING DEVICES WERE RETURNED TO VYGON; AN EVALUATION AND INVESTIGATION ARE UNDERWAY. THE RESULTS OF THIS INVESTIGATION WILL BE COMMUNICATED TO FDA IN A FOLLOW-UP MDR WITHIN THIRTY DAYS OF ITS CONCLUSION.

    Description of Event or Problem · 1

    SET FOUND TO BE LEAKING AT THE CONNECTION WHERE THE THREE LEGS JOIN. THE LEAKING WAS NOTICED BEFORE THE SET WAS USED ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46103 7 MICROBORE TRIFURCATED EXTENSION SET INTRAVASCULAR ADMINISTRATION SET FPA VYGON CORP. AMS-530 1306034

    Patients

    Seq Age Sex Outcome Treatment
    1