BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD FIRST PICC PERIPHERALLY INSERTED CENTRAL CATHETER

    MDR report key: 852064 · Received May 16, 2007

    Report

    Report Number
    1710034-2007-00042
    Event Type
    Other
    Date Received
    May 16, 2007
    Date of Event
    April 2, 2007
    Report Date
    May 9, 2007
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS A ROOT CAUSE ANALYSIS COULD NOT BE PERFORMED AS THE SAMPLE WAS NOT RECEIVED FOR ANALYSIS. THE DEVICE HISTORY COULD NOT BE REVIEWED AS A LOT NUMBER FOR THIS INCIDENT WAS NOT PROVIDED. THE USER IS ADVISED THAT THE CATHETERS ARE FRAGILE AND TO BE HANDLED WITH CARE. DATE SUBMITTED: 16 MAY 2007.

    Description of Event or Problem · 1

    THE CATHETER WAS INSERTED TO 19CM, THEN PULLED BACK 4CM. THE CATHETER BROKE WHEN THE BABY GRABBED THE IV TUBING. THE UNIT WAS INADVERTENTLY DISCARDED BY HOSPITAL STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD FIRST PICC PERIPHERALLY INSERTED CENTRAL CATHETER PERCUTANEOUS CATHETER LJS BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. NA 384232

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other