BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2212297 · Received August 15, 2011

    Report

    Report Number
    2090040-2011-00017
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    STRYKER SUSTAINABILITY SOLUTIONS (SSS) RESTERILIZED THE COMPLAINT DEVICE THROUGH OUR OPEN-BUT-UNUSED PROCESS. AN INVESTIGATION DETERMINED THE DEVICE LENGTH WAS 45MM HOWEVER THE ORIGINAL MANUFACTURE INSERT CARD WAS LABELED WITH A LENGTH OF 55MM. IT COULD HAVE BEEN SENT TO SSS WITH THE INCORRECT OEM INSERT CARD, OR IT COULD HAVE BEEN INSERTED BACK INTO THE INCORRECT DEVICE PACKAGE AT SSS DURING THE REPACKAGING PROCESS. THE LABELING DISCREPANCY WAS FOUND WHILE THE DEVICE WAS IN INVENTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN INVENTORY, IT WAS NOTICED THAT A TRACHEOSTOMY TUBE APPEARED TO BE A DIFFERENT LENGTH THAN WHAT WAS REPORTED ON THE LABEL. THE DEVICE WAS NEVER USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A JOH JOH 355-5.5

    Patients

    Seq Age Sex Outcome Treatment
    1