BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD L-CATH PERIPHERALLY INSERTED CENTRAL CATHETER

    MDR report key: 854686 · Received May 22, 2007

    Report

    Report Number
    1710034-2007-00047
    Event Type
    Other
    Date Received
    May 22, 2007
    Date of Event
    April 25, 2007
    Report Date
    May 17, 2007
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RECEIVED ON 17 MAY 2007 AND SENT FOR DECONTAMINATION. ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS INCIDENT. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PHYSICIAN INSERTED CATHETER. IMMEDIATELY AFTER INSERTION, THE PHYSICIAN FLUSHED THE CATHETER AND REALIZED THAT THE CATHETER WAS LEAKING. UPON FURTHER OBSERVATION, IT WAS NOTED THAT THE CATHETER HAD BROKEN AT THE TUB.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other