BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 2-LUMEN 4 FR X 8 CM

    MDR report key: 2193269 · Received July 13, 2011

    Report

    Report Number
    1036844-2011-00233
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    May 8, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE NIGHT IN THE PEDIATRIC UNIT, THE LUMEN WAS SEPARATED FROM THE DEVICE AND FOUND ON THE FLOOR. AS A RESULT, THE CATHETER WAS REMOVED, BUT NOT REPLACED. THERE WAS NO REPORTED DEATH OR COMPLICATIONS TO THE PT. THE HOSPITAL NOTED THAT THERE WAS NO DIFFICULTY EXPERIENCED DURING THE PROCEDURE AND A NON-CONFORMANCE WAS REPORTED FROM THE WARD NIGHT SHIFT. ADD'L INFO RECEIVED FROM THE DISTRIBUTOR ON (B)(6) 2011 STATED THAT NO BLOOD LOSS WAS REPORTED AND THE CHILD WAS (B)(6) YR/OLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 2-LUMEN 4 FR X 8 CM PEDIATRIC MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 MO