BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEARDUCT CATHETER

    MDR report key: 1968538 · Received December 23, 2010

    Report

    Report Number
    1318694-2010-00014
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Report Date
    December 23, 2010
    Manufacturer
    NUMED, INC.
    Product Code
    HNW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LONGITUDINAL BALLOON BURST WAS CONFIRMED. THIS IS USUALLY CONSISTENT WITH INFLATION ABOVE THE RATED BURST PRESSURE, HOWEVER, THE REPORT STATES THAT IT BURST RIGHT AT THE RATED BURST PRESSURE. THE CATHETER IS RATED FOR 14ATM. THE DEVICE FROM THE CONTROLLED INVENTORY WAS TESTED FOR RATED BURST PRESSURE. IT BURST AT 18ATM WHICH IS WELL ABOVE THE LABELED RATED BURST PRESSURE. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    BALLOON BURST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEARDUCT CATHETER DACRYOCYSTOPLASTY CATHETER HNW NUMED, INC. 352 TD-0044

    Patients

    Seq Age Sex Outcome Treatment
    1