BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTERIAL LINE KIT

    MDR report key: 3964249 · Received June 19, 2014

    Report

    Report Number
    1036844-2014-00274
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 18, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K810675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER WAS BEING PLACED IN THE NCCU. DURING INSERTION, THE WIRE BECAME STUCK IN THE NEEDLE AND UNRAVELED. AS A RESULT, EVERYTHING WAS REMOVED FROM THE PT AND A NEW KIT WAS USED SUCCESSFULLY. THEY DO NOT KNOW IF THIS CAUSED A DELAY IN TREATMENT AND NO PT DEATH OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360910 ARTERIAL LINE KIT ARTERIAL CATHETER PRODUCTS FOZ ARROW INTL., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1