BEUDAMED
    FDA Adverse Event Summary report: N

    BARD

    MDR report key: 3140812 · Received May 27, 2013

    Report

    Report Number
    MW5030342
    Date Received
    May 27, 2013
    Date of Event
    May 19, 2013
    Report Date
    May 27, 2013
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BARD POWER GLIDE 8CM CATHETER PLACED IN (B)(6) PT FOR INTRAVENOUS ADMINISTRATION OF FLUIDS AND MEDICATIONS ON (B)(6) 2013; EASILY PLACED BY EXPERIENCED RN USING SELDINGER TECHNIQUE, IN RIGHT FOREARM IN LARGE SUPERFICIAL VEIN W/O DIFFICULTY. LOT #REWJ0947. NURSE FIRST NOTED SWELLING OF HAND DISTAL TO SITE APPROX 12 HRS AFTER PLACEMENT. LINE CHECKED FOR PATENCY AND UNABLE TO DRAW BLOOD BACK OR FLUSH. DRESSING REMOVED AND CATHETER FELL OFF PT'S ARM. ONLY 1CM OF CATHETER FELL OFF PT'S ARM. ONLY 1CM OF CATHETER STILL ATTACHED TO HUB. THERE WAS NO REMAINING CATHETER VISIBLE. X-RAY'S COMPLETED AND REMAINING 7 CM OF CATHETER FOUND IN FOREARM APPROXIMATED 6 CM ABOVE ORIGINAL INSERTION SITE. SURGEON PERFORMED CUT-DOWN PROCEDURE AND REMOVED CATHETER. REGITINE INJECTED AROUND POWER GLIDE INSERTION SITE DUE TO POSSIBLE INFILTRATION OF DOPAMINE MEDICATION WHICH HAD BEEN INFUSING INTO PT PRIOR TO THIS EVENT. X-RAY OF RIGHT FOREARM CONFIRMED THAT A PIECE OF THE POWER GLIDE CATHETER HAD BROKEN OFF AND TRAVELED UP THE VEIN IN FOREARM. ELDERLY INTENSIVE CARE FEMALE PT WAS IMMOBILE AND HAD NOT BEEN RESTLESS OR COMBATIVE TO CAUSE DISLODGING OF CATHETER. NURSE PLACED CATHETER EASILY IN LARGE SUPERFICIAL VEIN WITH FLASH OF BLOOD NOTED IN CATHETER UPON INSERTION. SHE ADVANCED GUIDE WIRE SLOWLY, HOLDING HAND STEADY AND CLICKED INTO PLACE PER INSTRUCTIONS. SHE ADVANCED CATHETER USING CATHETER HANDLE. HELD CATHETER IN PLACE AND STEADILY PULLED BACK REMOVING HOUSING. CATHETER HANDLE REMOVED WITH GOOD BLOOD RETURN. CATHETER FLUSHED EASILY WITH 10 ML NORMAL SALINE. PT TOLERATED PROCEDURE WELL AND IV FLUID AND DOPAMINE STARTED AT 2300 ON (B)(6) 2013. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232685 BARD POWER GLIDE MIDLINE CATHETER 20G, 8CM DQO BARD ACCESS SYSTEMS, INC. REWJ0947

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Life Threatening| R