BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 3-LUMEN 7 FR X 16 CM

    MDR report key: 1230370 · Received November 7, 2008

    Report

    Report Number
    1036844-2008-00231
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 20, 2008
    Report Date
    November 7, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQO
    PMA / PMN Number
    K993691
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN THAT THE CATHETER WAS IN PLACE AND ONE OF THE LUMENS BROKE BELOW THE HUB. AS A RESULT, THE CATHETER WAS EXCHANGED OVER A GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT: 3-LUMEN 7 FR X 16 CM ARROWG+ARD CATHETER PROUCTS DQO ARROW INTL., INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK