BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFT TISSUE TIP

    MDR report key: 17585120 · Received August 18, 2023

    Report

    Report Number
    MW5144775
    Event Type
    Malfunction
    Date Received
    August 18, 2023
    Date of Event
    August 15, 2023
    Report Date
    August 15, 2023
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    FQH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ITEM 0210-012-000 SOFT TISSUE TIP WAS FOUND BROKEN EVEN THOUGH THE PACKAGE IS STILL SEALED. BLACK O RING THAT IS SUPPOSED TO BE ON THE ITEM ITSELF WAS BROKEN INTO PIECE WITHIN THE PACKAGE. WE LOCATED 2 ITEMS LIKE THAT IN CURRENT INVENTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1483510 SOFT TISSUE TIP LAVAGE, JET FQH STRYKER INSTRUMENTS 21166012

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown