BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERGLIDE MIDLINE CATHETER 20G, 8CM FULL INSERTION KIT

    MDR report key: 3193553 · Received June 25, 2013

    Report

    Report Number
    3006260740-2013-00315
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    May 20, 2013
    Report Date
    June 6, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    FOZ
    PMA / PMN Number
    K121073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR, AT THIS TIME, FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF (B)(4) SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    THE DEVICE TIP WAS VISUALLY INSPECTED PRIOR TO INSERTION AND APPEARED NORMAL. THE ENTIRE LENGTH OF THE CATHETER IS NOT VISIBLE BECAUSE IT IS ENCASED IN A PLASTIC HOUSING. A VEIN WAS SELECTED AND PREPPED AND WHEN THE NEEDLE BEVEL PENETRATED THE VESSEL WALL, QUICK BLOOD RETURN WAS NOTED AND THE ULTRASOUND IMAGE APPEARED TO CONFIRM NEEDLE TIP PLACEMENT IN THE LUMEN. THE GUIDEWIRE ON THE DEVICE WAS DEPLOYED WITHOUT ANY RESISTANCE. THE CATHETER WAS THEN SLOWLY AND SMOOTHLY ADVANCED WITHOUT ANY RESISTANCE. WHEN THE CATHETER WAS ABOUT 6-7 CM OF THE WAY IN, THE RN MET RESISTANCE AND IMMEDIATELY STOPPED ADVANCING. THE PT REPORTED HE COULD FEEL SOME PRESSURE. AFTER CHECKING THE ULTRASOUND IMAGE FOR CATHETER LOCATION, THE RN LOWERED THE ANGLE OF THE CATHETER AND TRIED TO ADVANCE THE CATHETER AGAIN, BUT MET THE SAME RESISTANCE. RN DECIDED TO WITHDRAW THE NEEDLE TO CHECK FOR BLOOD RETURN. THE NEEDLE WAS NOT WITHDRAWING SMOOTHLY AND THE CATHETER HANDLES WERE NOT LOOSENING. AT THIS POINT, THE RN DECIDED TO PULL THE ENTIRE DEVICE OUT AS ONE UNIT TO ABANDON THE PLACEMENT ATTEMPT. THERE WAS NO RE-ADVANCING OF THE NEEDLE AT ANYTIME. AS THE DEVICE WAS SLOWLY RETRACTED, THE RN SAW THE CATHETER WAS NOT INTACT AND IMMEDIATE STOPPED RETRACTING. A 3 CM OF CATHETER WAS INTACT ON THE NEEDLE. ULTRASOUND IMAGING CONFIRMED A CATHETER SEGMENT IN THE VESSEL. PRESSURE WAS MAINTAINED AT VASCULAR SITE TO PREVENT CATHETER EMBOLISM AND THE PT WAS TAKEN TO THE OPERATING ROOM FOR REMOVAL. A 5CM CATHETER SEGMENT WAS SUCCESSFULLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287281 POWERGLIDE MIDLINE CATHETER 20G, 8CM FULL INSERTION KIT FOZ C. R. BARD INC. (BASD) REWI0985

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention