BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 3-LUMEN 7 FR X 30 CM

    MDR report key: 3964274 · Received June 19, 2014

    Report

    Report Number
    1036844-2014-00277
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 19, 2014
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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 SICU, THE PHYSICIAN STATED THAT THE SWG WAS TOO SOFT AND EASILY KINKED DURING INSERTION. AS A RESULT, A NEW KIT WAS OPENED AND USED WITHOUT ISSUE. A DELAY WAS REPORTED, HOWEVER, NO DEATH OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360966 CVC SET: 3-LUMEN 7 FR X 30 CM ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTERNATIONAL INC. 23F13J0842

    Patients

    Seq Age Sex Outcome Treatment
    1