BEUDAMED
    FDA Adverse Event Other Summary report: N

    HIP DRAPE TIBURON

    MDR report key: 1294578 · Received January 26, 2009

    Report

    Report Number
    1423507-2009-00015
    Event Type
    Other
    Date Received
    January 26, 2009
    Date of Event
    December 4, 2008
    Report Date
    January 26, 2009
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE CUSTOMER REPORTS THAT THE SAMPLE WAS SENT HOWEVER, AS OF THIS DATE CARDINAL HAS NOT RECEIVED THE SAMPLE. SINCE THE SAMPLE WAS NOT RECEIVED, THE ACTUAL ROOT CAUSE COULD NOT BE DETERMINED. THE PERSONNEL INVOLVED WITH MANUFACTURING AND THE RAW MATERIAL SUPPLIER WERE INFORMED OF THIS COMPLAINT. AT THIS TIME WE ARE UNABLE TO CONFIRM THE REPORT BUT WILL CONTINUE TO MONITOR FOR ANY ADDITIONAL REPORTS OF THIS NATURE.

    Description of Event or Problem · 1

    PHYSICIAN REPORTS THAT WHILE DRAPING A PT WHO WAS UNDER GENERAL ANESTHESIA, THE CLEAR PLASTIC POUCH ON THE DRAPE WAS SEEN TO BE COVERED WITH A RESIDUE (LIKE THE SPOTS SEEN ON DISHES AFTER BEING WASHED IN THE DISHWASHER). THE DRAPE WAS REMOVED, AND THE ENTIRE SETUP OF EQUIPMENT FOR THE HIP REPLACEMENT WAS CONSIDERED CONTAMINATED. THE PT REMAINED UNDER ANESTHESIA FOR AN ADDITIONAL HOUR WHILE NEW INSTRUMENTS AND DRAPES WERE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIP DRAPE TIBURON SURGICAL DRAPE KKX CARDINAL HEALTH 08HRR209

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other