BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVC SET: 2-LUMEN 8FR X 20CM

    MDR report key: 2950256 · Received February 6, 2013

    Report

    Report Number
    1036844-2013-00045
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    October 5, 2012
    Report Date
    February 1, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT BEING RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN ANESTHESIA, THE PT WENT INTO SHOCK DUE TO AN ALLERGY TO CHLORHEXIDINE. THIS WAS CONFIRMED BY A BLOOD TEST AND AS A RESULT, THE CATHETER WAS REMOVED FROM THE PT AND REPLACED WITH A NON ARROW CATHETER. AFTER AN EMERGENCY TREATMENT, THE INTRA OPERATIVE RESUSCITATION CONSISTING OF IV FLUIDS, BOLUSES OF EPINEPHRINE, VASOPRESSIN, AND CARDIAC MASSAGE, THE PT RECOVERED. A DELAY WAS REPORTED, HOWEVER, THERE WAS NO ADDITIONAL HARM TO THE PT DUE TO THIS DELAY OR AS A RESULT OF THIS OCCURRENCE. THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49703 CVC SET: 2-LUMEN 8FR X 20CM ARROWG+AND CATHETER PRODUCTS FOZ ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention