BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVCF SET: 6-LUMEN 7FR X 2 0 CM

    MDR report key: 3050256 · Received April 5, 2013

    Report

    Report Number
    3006425876-2013-00046
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    March 24, 2013
    Report Date
    April 4, 2013
    Manufacturer
    ARROW INTERNATIONAL 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 INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE ICU, THE HUB SEPARATED FROM THE EXTENSION LINE. AS A RESULT, THE CATHETER WAS REMOVED AND 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
    141942 CVCF SET: 6-LUMEN 7FR X 2 0 CM ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK