BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 2-LUMEN 5 FR X 13 CM

    MDR report key: 2150538 · Received June 22, 2011

    Report

    Report Number
    1036844-2011-00200
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 17, 2011
    Report Date
    June 20, 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
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROX TWO MONTHS AFTER THE CATHETER WAS INDWELLED IN THE 3 YEAR OLD FEMALE PT, THE USER FOUND BLOOD LEAKING BETWEEN THE EXTENSION LINE OF THE PROXIMAL LUMEN AND ITS INJECTION HUB. AS A RESULT, THE CATHETER WAS REMOVED FROM THE PT'S RIGHT SUBCLAVIAN VEIN AND REPLACED WITH A NEW ONE. THE CATHETER WAS INSERTED EARLY (B)(6) 2011 AND THE REMOVAL DATE WAS (B)(6) 2011, THE DAY THE LEAK WAS FOUND. THE CATHETER WAS PULLED WHEN THE 3 YEAR OLD PT WAS PLAYING IN THE PLAY ROOM ABOUT A WEEK BEFORE THE EVENT OCCURRED. IT IS UNK IF THE PROXIMAL LUMEN WAS BEING USED FOR INFUSION OR BEING HEPARIN LOCKED AT THE TIME THE EVENT OCCURRED. THE BLUE BOX CLAMP WAS USED AS A SECONDARY SUTURE SITE. THERE WAS NO PT DEATH, INJURY OR COMPLICATIONS. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THE PT OUTCOME IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 2-LUMEN 5 FR X 13 CM PEDIATRIC MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTL., INC. RF0074497

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR