BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACUVANCE PLUS

    MDR report key: 567569 · Received January 11, 2005

    Report

    Report Number
    567569
    Event Type
    Other
    Date Received
    January 11, 2005
    Date of Event
    January 10, 2005
    Report Date
    January 11, 2005
    Manufacturer
    MEDEX INC.
    Product Code
    FPA
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RN ATTEMPTED TO START IV WITH ACUVANCE PLUS 18 GAUGE IV CATHETER- ADVANCED NEEDLE & CATHETER, THEN ADVANCED JUST CATHETER- NO BLOOD RETURN- ADVANCED NEEDLE INTO CATHETER AND ATTEMPTED TO PUSH FURTHER UP VEIN- AGAIN ATTEMPTED TO ADVANCE CATHETER WITHOUT SUCCESS- REMOVED NEEDLE STYLUS THEN REMOVED CATHETER & NOTICED CATHETER WAS ONLY 1/2 THERE. LEFT TURNIQUET ON ARM AND NOTIFIED ANESTHESIA WHO ARRANGED FOR GENERAL SURGEON TO SURGICALLY REMOVE CATHETER TIP. PATIENT TOLERATED WELL UNDER LOCAL ANESTHESIA. TIP SENT TO PATHOLOGY. QUESTION REMAINS WHETHER RN SHEARED OFF CATHETER OR IF MANUFACTORING DEFECT. MANUFACTURER CONTACTED- MEDEX, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVANCE PLUS IV CATHETER FPA MEDEX INC. 18 GAUGE 1 1/4' CATHETER 34G13SE02

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR PRENATAL MEDICATION