BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 2-LUMEN 8FR X 2 0CM

    MDR report key: 2061522 · Received March 16, 2011

    Report

    Report Number
    1036844-2011-00087
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 10, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER 72 HOURS IN USE, THE EXTENSION LINE OF THE DISTAL LUMEN WAS FOUND BROKEN WHEN THE NURSE HELPED THE PT ROLL OVER. A NEW KIT WAS OPENED AND USED WITHOUT ISSUE. THERE WAS NO REPORTED DELAY, DEATH OR COMPLICATIONS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 2-LUMEN 8FR X 2 0CM ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK