BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 2-LUMEN 7FR X 20 CM

    MDR report key: 2904023 · Received January 3, 2013

    Report

    Report Number
    1036844-2013-00003
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    November 16, 2012
    Report Date
    January 3, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT WAS INITIALLY EVALUATED AND DETERMINED TO BE NON-REPORTABLE. UPON RECEIPT OF THE RETURNED DEVICE ON (B)(4) 2013, THE EVENT WAS DETERMINED TO BE A RESULT OF A PRODUCT MALFUNCTION, THEREFORE IS REPORTABLE. FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER WAS BEING PLACED INTO THE PT'S FEMORAL VEIN IN THE PT'S ROOM. THEY EXPERIENCED DIFFICULTY WHEN ATTEMPTING TO REMOVE THE WIRE AFTER THE CATHETER WAS INSERTED. THEY WERE UNABLE TO REMOVE THE WIRE. AS A RESULT, BOTH THE WIRE AND CATHETER WERE REMOVED AND A NEW KIT WAS USED SUCCESSFULLY. THERE WAS NO DELAY IN TREATMENT AND NO PT DEATH OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3550 CVC KIT: 2-LUMEN 7FR X 20 CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTL., INC. RF1060111

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK