BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 3-LUMEN 7FR X 2 0CM

    MDR report key: 1133073 · Received August 22, 2008

    Report

    Report Number
    1036844-2008-00154
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 15, 2008
    Report Date
    August 22, 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
    TW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSERTION, BUBBLES WERE NOTICED AT THE NEEDLE WHEN THE CLINICIAN ATTEMPTED TO WITHDRAW BLOOD USING THE SYRINGE. THERE WERE NO REPORTED PT COMPLICATIONS. ADDITIONAL INFO FROM CONTACT STATED "THAT THE FRACTURES WERE AT THE NEEDLE HUB. IN ADDITION, OUR CUSTOMERS ARE EXPERIENCING DEFAULT PRODUCT IN THIS NATURE, (FRACTURE FOUND AT NEEDLE HUB) QUITE OFTEN RECENTLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 3-LUMEN 7FR X 2 0CM ARROWG+ARD CATHETER PRODUCTS DQO ARROW INTL., INC. RF7125585

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK