BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD L-CATH PERIPHERALLY INSERTED CENTRAL CATHETER

    MDR report key: 1169638 · Received September 18, 2008

    Report

    Report Number
    1710034-2008-00119
    Event Type
    Other
    Date Received
    September 18, 2008
    Date of Event
    June 2, 2008
    Report Date
    September 3, 2008
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS NOT AVAILABLE FOR THE INVESTIGATION. IF ADDITIONAL INFO IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE REPORTED LOT NUMBER, 7151925, AND NO IRREGULARITIES WERE NOTED DURING THE LOT'S MANUFACTURE.

    Description of Event or Problem · 1

    THE PICC LINE WAS PLACED IN THE ANTECUBITAL AREA AND BROKE THREE DAYS AFTER INSERTION. THE LINE BROKE WHERE THEY ARE "LOOPING" THE CATHETER UNDER THE DRESSING, BELOW THE STRAIN RELIEF COLLAR, OUTSIDE THE INSERTION SITE. NO PROBLEMS WERE NOTED DURING INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD L-CATH PERIPHERALLY INSERTED CENTRAL CATHETER PERCUTANEOUS CATHETER LJS BECTON DICKINSON INFUSION THERAPY SYSTEMS NA 7151925

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK