BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIRST PICC PERIPHERALLY INSERTED CENTRAL CATHETER

    MDR report key: 767853 · Received October 3, 2006

    Report

    Report Number
    1710034-2006-00085
    Event Type
    Other
    Date Received
    October 3, 2006
    Date of Event
    August 31, 2006
    Report Date
    September 6, 2006
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    D.10, H.3: THE HOSPITAL IS CURRENTLY HAVING THE SAMPLE INVESTIGATED AT AN INDEPENDENT TESTING FACILITY. THE HOSPITAL STATED THAT THEY WILL RETURN THE SAMPLE TO BD MEDICAL ONCE THE INDEPENDENT TESTING FACILITY HAS COMPLETED THEIR INVESTIGATION. DATE SUBMITTED: 09/29/2006.

    Description of Event or Problem · 1

    THE CATHETER WAS INSERTED IN 2006. 12 CM OF THE CATHETER WAS INSERTED INTO THE PATIENT AND 3 CM OF THE CATHETER REMAINED OUTSIDE OF THE PATIENT. TAPE WAS APPLIED ON THE CATHETER TUBING. THE CATHETER WAS FLUSHED WITH NORMAL SALINE USING A 10ML SYRINGE. FOUR DAYS LATER, THE CLINICIAN NOTICED THAT THE CATHETER WAS LEAKING. UPON FURTHER INSPECTION, THE CLINICIAN FOUND THAT THE CATHETER BROKE AT THE MOLDED JUNCTION. THE CATHETER WAS HOOKED TO A BED SIDE PUMP AT THE TIME THE BREAK OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST PICC PERIPHERALLY INSERTED CENTRAL CATHETER PERCUTANEOUS CATHETER LJS BECTON DICKINSON INFUSION THERAPY SYSTEMS NA 5299576

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other LIPIDS| TPN