BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 3202067 · Received June 27, 2013

    Report

    Report Number
    1721504-2013-00134
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K875196
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED SUSPECT DEVICE AND ONE UNUSED DEVICE WERE RETURNED FOR EVAL. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. THE COMPLAINT DATABASE WAS REVIEWED AND FOUND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. UPON VISUAL INSPECTION THE COMPLAINT WAS CONFIRMED. THE SYRINGE TIP HAD DETACHED FROM THE PLUNGER OF THE USED DEVICE. THERE DID NOT APPEAR TO BE ANY REMAINING LUBRICANT LEFT IN THE SYRINGE. THE TIP WAS REATTACHED TO THE PLUNGER AND TESTED. QUICKLY PULLING BACK ON THE SYRINGE CAUSED THE TIP TO DETACH FROM THE PLUNGER. AN ANALYSIS OF THE SYRINGE TIP REVEALED THAT ALL DIMENSIONS WERE WITHIN THE ESTABLISHED SPECS. THE UNUSED DEVICE WAS ALSO TESTED. QUICKLY PULLING BACK ON THE SYRINGE DID NOT CAUSE THE PLUNGER TIP TO DETACH. A VISUAL EXAMINATION OF THE UNUSED DEVICE REVEALED THAT THERE WAS AN ADEQUATE AMOUNT OF LUBRICANT IN THE SYRINGE. MERIT IS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE USER REPORTED THAT DURING A CORONARY ANGIOGRAM PROCEDURE THE PLUNGER TIP OF THE SYRINGE INCLUDED IN THE KIT DETACHED FROM THE PLUNGER WHEN THE USER PULLED BACK ON THE SYRINGE. THE USER STATED THAT THIS HAS OCCURRED SEVERAL TIMES BUT DID NOT PROVIDED ANY ADD'L CLINICAL DETAILS. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293333 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. H442514

    Patients

    Seq Age Sex Outcome Treatment
    1