BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 3-LUMEN 5.5 FR X 8 CM

    MDR report key: 4253309 · Received November 12, 2014

    Report

    Report Number
    1036844-2014-00456
    Event Type
    Malfunction
    Date Received
    November 12, 2014
    Date of Event
    October 12, 2014
    Report Date
    November 6, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE INSERTION OF A CVC INTO THE INTERNAL JUGULAR VEIN THE SGW WAS NOT GOING THROUGH PROPERLY. IT HAD TO BE REMOVED WITHOUT ANY FORCE, BUT IT BROKE DURING THE REMOVAL. AS A RESULT, A METALLIC THREAD OF 8 TO 10 CM REMAINED IN THE NEEDLE BLOCKING THE LIGHT. THE DEVICE HAD TO BE REMOVED AND REPLACED BY A DIFFERENT LOT NUMBER. THERE WERE NO CLINICAL CONSEQUENCES FOLLOWING THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729476 CVC SET: 3-LUMEN 5.5 FR X 8 CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTL., INC. 23F13L0878

    Patients

    Seq Age Sex Outcome Treatment
    1