BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERPULSE YANKAUER TIP

    MDR report key: 3964932 · Received July 29, 2014

    Report

    Report Number
    0001811755-2014-02696
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 17, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FQH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTERPULSE YANKAUER TIP WAS BEING OPENED FOR USE WHEN THE PACKAGING WOULD NOT OPEN CLEANLY CAUSING THE MATERIAL TO SHRED, THUS COMPROMISING THE STERILITY OF THE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITH NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440973 INTERPULSE YANKAUER TIP LAVAGE, JET FQH STRYKER INSTRUMENTS-KALAMAZOO 3141101141340124

    Patients

    Seq Age Sex Outcome Treatment
    1