BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD POWERPICC

    MDR report key: 1565527 · Received December 22, 2009

    Report

    Report Number
    MW5014109
    Event Type
    Malfunction
    Date Received
    December 22, 2009
    Date of Event
    December 22, 2009
    Report Date
    December 22, 2009
    Manufacturer
    BARD MEDICAL DIVISION, BARD MEDICAL
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A PICC LINE INSERTION OF A BARD POWERPICC - CATALOG # 3275108, LOT RESH0343, THE TWO NURSES HAD DIFFICULTY REMOVING THE GUIDEWIRE. AFTER SOME EFFORT, THE NURSES RETRIEVED THE GUIDEWIRE, DISCOVERING THAT THE WIRE HAD UNRAVELED. APPROX 10 CM OF THE WIRE UNRAVELED WITH AN 18 CM SEGMENT RESEMBLING A FINE SPRING REPRESENTING THE SECOND SEGMENT. ON GROSS EXAMINATION, IT DOES NOT APPEAR THAT ANY OF THE WIRE BROKE OFF INTO THE PT; HOWEVER, A STAT CXR IS PENDING. I IMMEDIATELY NOTIFIED BARD MEDICAL, FIELD ASSURANCE MANAGER, OF THE INCIDENT. I WAS TOLD BARD WILL SEND A BIOHAZARD BOX TO MY FACILITY FOR ME TO RETURN THE DEVICE TO THEM FOR INVESTIGATION. DATES OF USE: 2007 - 2009. DIAGNOSIS OR REASON FOR USE: IV FLUID/MEDICATION ADMINISTRATION. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD POWERPICC POWERPICC LJS BARD MEDICAL DIVISION, BARD MEDICAL 3275108 RESH0343

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other