BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTED PERIPHERALLY INSERTED CENTRAL CATHETER

    MDR report key: 3901659 · Received May 6, 2014

    Report

    Report Number
    3006260740-2014-00230
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Report Date
    April 15, 2014
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    DURING THE PLACEMENT OF A PICC LINE, AFTER THEY THREAD THE CATHETER OVER THE WIRE, THEY WERE UNABLE TO PULL THE WIRE BACK AND WHEN THEY PULLED THE WIRE BACK IT WAS SHEARED OFF. THE PATIENT WAS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271926 IMPLANTED PERIPHERALLY INSERTED CENTRAL CATHETER CATHER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM LJS BARD ACCESS SYSTEMS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention