BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 2-LUMEN 5 FR X 13 CM

    MDR report key: 3972908 · Received April 28, 2014

    Report

    Report Number
    1036844-2014-00195
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    March 7, 2014
    Report Date
    April 21, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN ER-PEDIATRICS DURING INSERTION, THE USER NOTED THAT THE SWG KINKED AND AS A RESULT NEED TO BE REMOVED ALONG WITH THE CATHETER. THE PATIENT WAS A (B)(6) MALE REQUIRING CENTRAL ACCESS DUE TO SUPRAVENTRICULAR TACHYCARDIA. THE PUNCTURE SITES WERE THE SUBCLAVIAN AND FEMORAL VEINS. A NEW KIT WAS OPENED AND USED, HOWEVER THE SAME ISSUE OCCURRED. A DELAY WAS REPORTED, HOWEVER, THERE WERE NO REPORTED COMPLICATIONS OR DEATH TO THE PATIENT. A TOTAL OF FOUR EVENTS OCCURRED. THE OTHER THREE EVENTS ARE MDRS 1036844-2014-00196, 1036844-2014-00197, AND 1036844-2014-00198.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253484 CVC SET: 2-LUMEN 5 FR X 13 CM PEDIATRIC MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTL., INC. RF3027143

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR