BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 4-LUMEN 8.5 FR X 20 CM

    MDR report key: 3810661 · Received March 24, 2014

    Report

    Report Number
    3006425876-2014-00078
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    February 28, 2014
    Report Date
    March 19, 2014
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE ICU WHEN INSERTING THE DILATOR OVER THE SWG PLACED IN THE PT'S LEFT SUBCLAVIAN VEIN, THE SWG KINKED (SEE MDR 3006425876-2014-00053) RESULTING IN THE DAMAGING OF THE TIP OF THE DILATOR. AS A RESULT, A NEW KIT WAS OPENED HOWEVER, THE SAME ISSUE OCCURRED (SEE MDRS 3006425876-2014-00054 AND 3006425876-2014-00079). A NON-TELEFLEX KIT WAS THEN USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED DELAY, DEATH, OR COMPLICATIONS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172515 CVC SET: 4-LUMEN 8.5 FR X 20 CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTERNATIONAL INC. 71F13H0972

    Patients

    Seq Age Sex Outcome Treatment
    1