BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMA ANGIOGRAPHIC CATHETERS

    MDR report key: 3101633 · Received May 3, 2013

    Report

    Report Number
    1721504-2013-00103
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 26, 2013
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K943739
    Removal / Correction Number
    1721504-5/2/13-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE SUSPECT DEVICE HAS NOT BEEN RECEIVED FOR EVAL. THE USER INDICATED THEY OPENED ONE DEVICE AND DISCOVERED THE DEFECT. THE USER CHECKED ALL (B)(4) UNITS IN THEIR INVENTORY AND THEY ARE DEFECTIVE AND WILL BE RETURNED. MERIT DETERMINED ON 04/26/2013 THAT A PRODUCT REMOVAL WOULD BE REQUIRED FOR FIVE (5) SPECIFIC LOTS OF THE MERIT PERFORMA CARDIAC MULTIPACK I AND II BECAUSE THE JUDKINS RIGHT 4.0 CATHETER CONTAINED WITHIN THE KITS HAS A SLIGHT VARIATION IN THE TIP SHAPE. COMMUNICATIONS TO CONSIGNEES BEGAN ON 05/02/2013. A REPORT TO THE FDA IN ACCORDANCE WITH 21 CFR 806.10 IS IN PROCESS AND WILL BE SENT WITHIN THE TEN DAY REQUIREMENT OF INITIATING FIELD ACTION. MERIT CONTACTED THE (B)(4) DISTRICT OFFICE ON 04/30/2013 AND INFORMED THEM OF MERIT'S INTENT TO BEGIN FIELD ACTION AND PROVIDED A COPY OF MERIT'S HEALTH HAZARD EVAL FOR THIS FAILURE MODE. ROOT CAUSE IS ATTRIBUTED TO THE MFG PROCESS. CORRECTIVE ACTIONS FOR THIS FAILURE MODE HAVE BEEN IMPLEMENTED. NO ADDITIONAL FORM FDA3500A REPORTS WILL BE FILED FOR THIS EVENT.

    Description of Event or Problem · 1

    THE USER REPORTED THE JUDKINS RIGHT CATHETER DOES NOT HAVE THE CORRECT TIP SHAPE. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194637 PERFORMA ANGIOGRAPHIC CATHETERS CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. I662390

    Patients

    Seq Age Sex Outcome Treatment
    1