BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 2-LUMEN 5FR X 13 CM

    MDR report key: 3982817 · Received July 2, 2014

    Report

    Report Number
    1036844-2014-00292
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    April 28, 2014
    Report Date
    June 27, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS EVENT OCCURRED IN THE (B)(6) PEDIATRICS DEPARTMENT. THIS EVENT INVOLVED A (B)(6) YR/OLD FEMALE PATIENT, (B)(6), SUFFERING FROM ACUTE RESPIRATORY FAILURE AND RENAL INSUFFICIENCY. THE PHYSICIAN REPORTED THAT DURING INSERTION OF THE CVC INTO THE PATIENT'S RIGHT SUBCLAVIAN VEIN, REALIZED THAT THE SWG WAS BENT, MAKING IT IMPOSSIBLE TO ADVANCE THE CATHETER OVER THE SWG, WHICH COULD HAVE CAUSED INJURY TO THE PATIENT. AS A RESULT, THE CATHETER AND SWG WERE REMOVED INTACT, AND REPLACED WITH ANOTHER FROM THE SAME LOT. AS A RESULT, A SECOND KIT WAS OPENED. THERE WAS NO DELAY, HARM, COMPLICATION, OR INJURY REPORTED TO THE PATIENT. SEE MDR 1036844-2014-00293 FOR THE SECOND EVENT WITH THE SAME PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387078 CVC SET: 2-LUMEN 5FR X 13 CM PEDIATRIC MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTL., INC. RF3027143

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR