BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    105" IV ADMINISTRATION SET W/BIONECTOR

    MDR report key: 6520761 · Received April 25, 2017

    Report

    Report Number
    2245270-2017-00013
    Event Type
    Malfunction
    Date Received
    April 25, 2017
    Date of Event
    March 1, 2017
    Report Date
    April 25, 2017
    Manufacturer
    VYGON MFG
    Product Code
    FPA
    PMA / PMN Number
    K011336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VYGON US RECEIVED ONE (1) SAMPLE OF THE DEVICE BN-602 LOT 1608061D FOR EVALUATION, THE UNIT WAS TESTED FOR A PIN HOLE LEAK IN THE IV TUBING DRIP SET. THERE WAS NO PIN HOLE OBSERVED, HOWEVER THE SET IMMEDIATELY BEGAN TO LEAK AT THE BOND AREA OF THE DRIP CHAMBER TO TUBE AND WAS CONFIRMED THERE WAS A FLUID LEAK. A REVIEW OF THE LOT HISTORY RECORD FOR THE LOT LISTED ON THE PIR REPORT WAS CONDUCTED FOR THIS PRODUCT. THE QC INSPECTION REPORT INDICATES ZERO FINDINGS FOR LEAK TESTING DURING THIS LOT MANUFACTURED IN AUGUST OF 2016. ALL PRODUCTION AND QC PERSONNEL ARE UP TO DATE WITH THEIR TRAINING. CORRECTIVE ACTION: AS AN IMMEDIATE ACTION VYGON HAS STOPPED MANUFACTURING WITH DRIP CHAMBERS FROM THIS SUPPLIER, AND CONVERTED ALL PRODUCTION BACK TO THE PREVIOUSLY QUALIFIED SUPPLIER. TRAINING WILL BE PERFORMED WITH ALL OPERATORS PERFORMING BONDING OPERATIONS. A CORRECTIVE ACTION WILL BE ISSUED INTO VYGON USA QUALITY MANAGEMENT SYSTEM TO DOCUMENT THE FORMAL TRAINING. VYGON USA WILL CONTINUE TO MONITOR THIS FAILURE MODE FOR FUTURE OCCURRENCES

    Description of Event or Problem · 1

    ON THE AFTERNOON OF (B)(6) 2017 AS IV ACCESS WAS BEING ESTABLISHED THE CREW MEMBERS NOTICED A PIN HOLE LEAK IN THE IV TUBING DRIP SET. A SECOND SET WAS THEN USED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299447 105" IV ADMINISTRATION SET W/BIONECTOR INTRAVASCULAR ADMINISTRATION SET FPA VYGON MFG 1608061D

    Patients

    Seq Age Sex Outcome Treatment
    1