BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICU/O2 & AEROSOL/CATHETER

    MDR report key: 3492123 · Received October 25, 2013

    Report

    Report Number
    3005778470-2013-00041
    Event Type
    Malfunction
    Date Received
    October 25, 2013
    Date of Event
    September 27, 2013
    Report Date
    September 27, 2013
    Manufacturer
    CONVATEC INC
    Product Code
    BZB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. NO REPORTS OF A PT BEING HARMED AS A RESULT OF THIS MALFUNCTION. ADD'L INFO RECEIVED INDICATES THAT SIXTEEN SAMPLES WITHOUT PEEL PACK WERE RECEIVED AND TESTED. RESULTS SHOW THAT TWELVE SAMPLES DID NOT MEET TEST REQUIREMENTS AND THAT THE FOAM DID COME LOOSE AT CATHETERS. FOR SAMPLES THAT WERE STRENGTH TESTED, RESULTS SHOW THAT ALL MET SPECS. HISTORY RECORDS WERE REVIEWED AND NO NONCONFORMITY OF THIS NATURE WAS REGISTERED DURING MFG PROCESS. ALL RELEVANT TESTS REQUIRED DURING MFG PROCESS AND FINAL PRODUCT RELEASES WERE PERFORMED AND MET REQUIREMENTS. NO EARLIER COMPLAINT HAS BEEN RECEIVED ON THE BATCH. NOTE: THE ACTUAL DATE OF EVENT IS UNK, SO THE DATE USED TO THE DATE CONVATEC BECAME AWARE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE FOAM PAD IS LOOSE AND THAT THE FOAM REMAINS IN THE PACKAGING CONTAINER UPON REMOVAL. IT IS REPORTED THAT THE FOAM STAYS IN THE NOSE OF THE PT. SIXTEEN SAMPLES WERE TAKEN TO A VISUAL EXAMINATION IN ACCORDANCE TO THE DRAWING (DEMANDED: FOAM SHOULD BE GLUED AT THE CATHETER; ACTUAL: THE FOAM IS LOOSE AT THREE SAMPLES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550496 ICU/O2 & AEROSOL/CATHETER CATHETER, NASAL, OXYGEN BZB CONVATEC INC 19057339 453346

    Patients

    Seq Age Sex Outcome Treatment
    1