BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    35" STANDARDBORE ADMINISTRATION SET

    MDR report key: 1934137 · Received December 8, 2010

    Report

    Report Number
    2245270-2010-00019
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    October 19, 2010
    Report Date
    December 8, 2010
    Manufacturer
    VYGON
    Product Code
    FPA
    PMA / PMN Number
    K011336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCTS WERE SENT TO THE SUPPLIER OF THE COMPONENT THAT WAS CITED TO BE LEAKING. RESULTS OF THE SUPPLIER'S INVESTIGATION WILL BE PROVIDED IN A FOLLOW UP MDR.

    Description of Event or Problem · 1

    SECONDARY SET LEAKED CHEMOTHERAPEUTIC AGENT FROM THE VENT CLOSURE SITE RIGHT AT THE START OF INFUSION. NEITHER THE PATIENT NOR THE CLINICIAN PREPPING THE INFUSION WERE HARMED BY THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 35" STANDARDBORE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA VYGON AMS-184-1 1008038

    Patients

    Seq Age Sex Outcome Treatment
    1