BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 3-LUMEN 7 FR X 20 CM

    MDR report key: 3915385 · Received May 28, 2014

    Report

    Report Number
    1036844-2014-00240
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 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 PULMONARY MEDICINE, THE PHYSICIAN WAS UNABLE TO SUCCESSFULLY PASS THE SWG THROUGH THE ARS RESULTING IN THE KINKING OF THE SWG. AS A RESULT, A NEW KIT WAS OPENED AND USED WITHOUT ISSUE. THERE WAS NO REPORTED DELAY, DEATH, OR COMPLICATIONS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314221 CVC KIT: 3-LUMEN 7 FR X 20 CM ARROWGARD CATHETER FOZ ARROW INTERNATIONAL INC. 23F13K0160

    Patients

    Seq Age Sex Outcome Treatment
    1