BEUDAMED
    FDA Adverse Event Other Summary report: N

    L-CATH PERIPHERALLY INSERTED CENTRAL CATHETER

    MDR report key: 794959 · Received November 28, 2006

    Report

    Report Number
    1710034-2006-00105
    Event Type
    Other
    Date Received
    November 28, 2006
    Date of Event
    October 17, 2006
    Report Date
    November 6, 2006
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
    Product Code
    LJS
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    H-6: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO DISCREPANCIES ASSOCIATED WITH THIS INCIDENT. A ROOT CAUSE ANALYSIS WAS UNABLE TO BE PERFORMED AS THE SAMPLE WAS NOT RETURNED.

    Description of Event or Problem · 1

    THE PT'S SKIN AT THE PICC LINE INSERTION SITE WAS NOTED TO BE PUCKERED. WHILE STAFF WAS HOLDING THE LINE IN ONE HAND, TENSION WAS APPLIED ON THE INSERTION SITE AND THE PICC LINE BROKE AT THE 9 CM MARK. THE LINE DISAPPEARED AT THE INSERTION SITE AND THE PICC LINE WAS SUBSEQUENTLY RETRIEVED BY THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L-CATH PERIPHERALLY INSERTED CENTRAL CATHETER PERCUTANEOUS CATHETER LJS BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. NA 6005581

    Patients

    Seq Age Sex Outcome Treatment
    1 49 DAY Required Intervention