BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL BLOCK TRAY

    MDR report key: 3190467 · Received June 21, 2013

    Report

    Report Number
    1722447-2013-00006
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    INTEGRA PAIN MANAGEMENT
    Product Code
    FMF
    PMA / PMN Number
    K960248
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013 CONFIRMED HOLES IN HOSPITAL WRAPS FOR FIVE OF SIX RETURNED TRAYS. ROOT CAUSE IS UNDETERMINED. FAILURE ANALYSIS: FOUR TRAYS WERE RETURNED WITH OPENED HEADER BAGS AND PRODUCT LABELS. TWO TRAYS WERE RETURNED WITHOUT HEADER BAGS OR PRODUCT LABEL. FOUR OF THE SIX HOSPITAL WRAPS HAD HOLES AT CORNERS OF THE TRAYS. ONE WRAP HAD A HOLE ALONG THE EDGE OF THE TRAY. ONE WRAP HAD SLIGHT DAMAGE ALONG THE FOLD NEAR THE CORNER OF THE TRAY THAT TORE THE PAPER LAYERS OF THE WRAP, BUT DID NOT PENETRATE THE PLASTIC LAYER. DEVICE HISTORY REVIEW: A REVIEW OF THE LOT HISTORY RECORD INDICATED THE INSPECTIONS WERE PERFORMED AS REQUIRED AND NO NONCONFORMANCE WAS FOUND DURING THE TRAY BUILD PROCESS. THERE AR NO RELATED VARIANCES, NCMRS, HHES OR CHANGE CONTROL. TREND ANALYSIS: A REVIEW OF COMPLAINTS FOR THE LAST TWO YEARS REVEALED SIMILAR COMPLAINTS RELATED TO DAMAGE HOSPITAL WRAPS. A CAPA HAS BEEN INITIATED. BASED ON THE REPORTED INFORMATION AND THE INVESTIGATION RESULTS PROVIDED, INTEGRA CONSIDERS THIS COMPLAINT CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    HOLE IN THE WHITE TRAY WRAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282548 UNIVERSAL BLOCK TRAY 44 TRAYS FMF INTEGRA PAIN MANAGEMENT S1301513

    Patients

    Seq Age Sex Outcome Treatment
    1