BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM KIT

    MDR report key: 1251933 · Received November 21, 2008

    Report

    Report Number
    1721504-2008-00060
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 22, 2008
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: THE SUSPECT DEVICE HAS BEEN RETURNED TO MERIT FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUBING CAME LOOSE FROM THE FLUSH PORT OF A FEMORAL ARTERY FLUSH LINE. THE NURSE ATTEMPTED TO RE-ATTACH THE TUBING WITHOUT SUCCESS. THE ARTERIAL SHEATH WAS REMOVED AND THE PT HAD A CBC (COMPLETE BLOOD COUNT) ORDERED. ANTIBIOTIC WAS ADMINISTERED AS A PRECAUTION. THERE WAS NO REPORTED HARM OR INJURY TO THE PT. THE SUSPECT DEVICE IS A PURCHASED COMPONENT INCLUDED IN THE MERIT CUSTOM KIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention SHEATH