BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM WASTE MANAGEMENT KIT

    MDR report key: 1161843 · Received September 12, 2008

    Report

    Report Number
    1721504-2008-00047
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 9, 2008
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    Removal / Correction Number
    1721504-09/09/08-008-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: DEVICE EVALUATION IN PROCESS, BUT NOT YET COMPLETE. EVALUATION CONCLUSIONS: ALL SUBSEQUENT INVESTIGATION RESULTS WILL BE SUBMITTED TO THE FDA IN A FOLLOW-UP MDR AND IN ACCORDANCE WITH STATUTORY PRODUCT RETRIEVAL REPORTING REQUIREMENTS.

    Description of Event or Problem · 1

    IN 2008, MERIT DETERMINED THAT A PRODUCT RETRIEVAL WAS REQUIRED AFTER INVESTIGATION OF COMPLAINTS REVEALED THAT SEVERAL DISPOSAL DEPOT BAGS WITHIN ONE LOT OF CUSTOM WASTE MANAGEMENT KITS WERE LEAKING, THEREBY RENDERING THE DEVICES UNUSABLE. PLEASE NOTE THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE COMPLAINTS BECAUSE THE DEFECTS WERE FOUND AT PREP. THERE HAVE BEEN NO REPORTS OF ADVERSE HEALTH EFFECTS ASSOCIATED WITH THIS RETRIEVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM WASTE MANAGEMENT KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. NA F622787

    Patients

    Seq Age Sex Outcome Treatment
    1