BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 2-LUMEN 5 FR X 13 CM

    MDR report key: 3820541 · Received April 11, 2014

    Report

    Report Number
    1036844-2014-00171
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    February 27, 2014
    Report Date
    April 8, 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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN PASSING THE CATHETER OVER THE SWG, THE SWG "DEFORMED." AS A RESULT, A NEW KIT WAS OPENED AND A NEW PUNCTURE WAS NEEDED ALONG WITH ADDITIONAL SEDATION TO SUCCESSFULLY COMPLETE THE PROCEDURE. A DELAY WAS REPORTED, HOWEVER, THERE WAS NO DEATH OR COMPLICATIONS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. THE PATIENT INVOLVED WAS A (B)(6) FEMALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221219 CVC SET: 2-LUMEN 5 FR X 13 CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTL., INC. 23F13H0721

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR