BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD L-CATH

    MDR report key: 1815106 · Received August 20, 2010

    Report

    Report Number
    1710034-2010-00036
    Event Type
    Other
    Date Received
    August 20, 2010
    Report Date
    June 30, 2010
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OBSERVATIONS AND TESTING: RECEIVED ONE USED 26 GA X 30 CM S/L L-CATH CATHETER WITH NO PACKAGING OR IDENTIFICATION INSERTS. THE SAMPLE WAS RECEIVED IN 2 PORTIONS AND WAS MICROSCOPIC ENHANCED TO INVESTIGATE THE AREA OF SEPARATION. CONCLUSIONS: CONFIRMATION OF THE SUBJECT (CATHETER BROKEN) WAS CONCLUSIVE WITH THE SAMPLE RECEIVED FOR INVESTIGATION. CONFIRMED SEPARATION OF THE CATHETER TUBING OCCURRED BELOW THE LAVENDER STRAIN RELIEF. THE SAMPLE REVEALED CONCLUSIVE EVIDENCE (FLARING AND DAMAGED, SMOOTH AND JAGGED EDGES ON AN UNEVEN BREAK) THAT THE CATHETER TUBING HAD RECEIVED EXCESSIVE STRESS AND DAMAGE BY A SHARP OBJECT OR INSTRUMENT (MISUSE/MISHANDLING). CORRECTIVE ACTION PROJECT: A CORRECTIVE ACTION PROJECT WILL NOT BE INITIATED FOR THIS SPECIFIC INCIDENT BECAUSE AS A RESULT OF THE INVESTIGATION, THERE WAS CONCLUSIVE EVIDENCE THAT THE FAILURE WAS CONTRIBUTED TO (MISUSE/MISHANDLING). (B)(4). DATE SUBMITTED: 08/20/2010.

    Description of Event or Problem · 1

    YELLOW EXUDATE, THOUGHT TO BE PUS, NOTED AT EXIT SITE. SWABBED AND NO GROWTH AND CATHETER TO BE REMOVED. HOWEVER, AT THE TIME OF REMOVAL, IT BROKE. IT WAS SUCCESSFULLY REMOVED SEVERAL HOURS LATER, VIA SURGERY. EXUDATE MAY HAVE BEEN LIPIDS FROM TPN. CATHETER WAS INSERTED TO HUB AND THEREFORE, UNABLE TO VIEW ANY PORTION OF THE CATHETER WHILE IT WAS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD L-CATH PERCUTANEOUS CATHETER DQY BECTON DICKINSON INFUSION THERAPY SYSTEMS NA 9187103

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other