BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUCATH ACE INTRAVASCULAR CATHETER

    MDR report key: 12107826 · Received July 1, 2021

    Report

    Report Number
    MW5102256
    Event Type
    Malfunction
    Date Received
    July 1, 2021
    Date of Event
    June 20, 2021
    Report Date
    June 25, 2021
    Manufacturer
    C. R. BARD, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON PLACEMENT OF A 20 G ACCUCATH IN THE RFA THE GUIDE WIRE (GW) WAS BEING REMOVED THE NURSE FELT SLIGHT RESISTANCE AND THEN A RELEASE OF THE GW. THE TIP OF THE CATHETER (COIL) BROKE OFF AND REMAINED IN THE PT'S VEIN. BARD NOTIFIED AND NOTED THAT THE FAILURE COULD BE RELATED TO ME LOT REFQ 1278. SUBJECT; 3110943 - PIR3017146 - ACKNOWLEDGMENT, SAMPLE, LOT NUMBER VERIFICATION AND ADDITIONAL INFORMATION REQUESTED. OUR REF : 3110943, EXTERNAL REF: PIR3017146, DATE OF INCIDENT: (B)(6) 2021, DATE REPORTED: 06/20/2021. PART NAME: ACCUCATH 22 GX1.25, PART NO: AC0221250, BATCH NO:, LOT PROVIDED: REFQ1278. DESCRIPTION OF COMPLAINT - IT WAS REPORTED "CUSTOMER ALERTED ME WIRE BROKE OFF WHEN PLACING ACCUCATH, NO PT HARM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994524 ACCUCATH ACE INTRAVASCULAR CATHETER CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ C. R. BARD, INC. REFQ 1278

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR