BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL BLOCK TRAY

    MDR report key: 3190468 · Received June 21, 2013

    Report

    Report Number
    1722447-2013-00004
    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 THAT FIVE RETURNED TRAYS HAD HOLES IN WRAPS. ROOT CAUSE IS UNDETERMINED. FAILURE ANALYSIS: FIVE TRAYS WERE RETURNED OUTSIDE OF HEADER BAGS. FOUR HEADER BAGS WITH FOUR PRODUCT LABELS FROM LOT S1210506 WERE RETURNED WITH THE TRAYS. TRAY #1 HAD ONE HOLD AT A CORNER OF THE TRAY AND ONE HOLE ON THE BOTTOM OF THE TRAY BETWEEN COMPARTMENTS OF THE SMALL PORTION OF THE SINGLE DECK TRAY. TRAY #2 HAD TWO HOLES AT OPPOSITE CORNERS OF THE TRAY. TRAY #3 HAD ONE HOLE ON A FOLD NEAR A CORNER OF THE TRAY. TRAY #4 HAD ONE HOLE ALONG THE EDGE OF THE TRAY. TRAY #5 HAD ONE HOLD ON A FOLD NEAR A CORNER OF THE TRAY. 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 ARE NO RELATED VARIANCES, NCMRS, HHES OR CHANGE CONTROL. TREND ANALYSIS: A REVIEW OF COMPLAINTS FOR THE LAST TWO YEARS REVEALED SIMILAR COMPLAINTS RELATED TO DAMAGED 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
    283528 UNIVERSAL BLOCK TRAY 44 TRAYS FMF INTEGRA PAIN MANAGEMENT

    Patients

    Seq Age Sex Outcome Treatment
    1