BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    35" STANDARDBORE ADMINISTRATION SET

    MDR report key: 2160287 · Received May 10, 2011

    Report

    Report Number
    2245270-2011-00023
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 10, 2011
    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

    A SUPPLIER CORRECTIVE ACTION REPORT WAS SUBMITTED TO THE SUPPLIER OF THE AFFECTED COMPONENTS ON (B)(6) 2011. THE USED DEVICE WAS NOT AVAILABLE OR RECEIVED FROM THE USER FACILITY. VYGON IS WORKING VERY CLOSELY AND ACTIVELY WITH THE SUPPLIER REGARDING THIS INCIDENT. A VISIT TO THE USER FACILITY WILL ALSO BE MADE. RESULTS OF THE INVESTIGATION WILL BE SENT IN A SUPPLEMENTAL MDR WITHIN A MONTH OF RECEIVING THE NEW INFO.

    Description of Event or Problem · 1

    SECONDARY SET WAS LEAKING A DRUG AT THE VENT CLOSURE SITE. NO PT HARM OCCURRED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 35" STANDARDBORE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA VYGON AMS-184-1 1012002

    Patients

    Seq Age Sex Outcome Treatment
    1