BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD L-CATH PERIPHERALLY INSERTED CENTRAL CATHETER

    MDR report key: 1172780 · Received September 18, 2008

    Report

    Report Number
    1710034-2008-00120
    Event Type
    Other
    Date Received
    September 18, 2008
    Date of Event
    August 21, 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

    ONE USED UNIT WAS RECEIVED ON 09/16/2008 AND IS CURRENTLY BEING DECONTAMINATED. UPON DECONTAMINATION AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B) (4)

    Description of Event or Problem · 1

    AFTER THE PICC CATHETER WAS INSERTED, THE NURSE WAS APPLYING THE DRESSING AND PLACING THE CATHETER, "LOOPING" IT UNDER THE DRESSING. THE CATHETER BROKE JUST BELOW THE PURPLE COLLAR AREA. A SECOND LINE WAS THEN PLACED AND THE EXACT PROBLEM OCCURRED, THE LINE BROKE APPROXIMATELY ONE INCH ABOVE THE PURPLE COLLAR AREA. THE CUSTOMER CONFIRMED THAT THE INSERTION WAS STRAIGHT FORWARD WITH NO DIFFICULTIES. A PERIPHERAL LINE WAS INSERTED AFTER THIS.

    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 8079496

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK