BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD L-CATH PERIPHERALLY INSERTED CENTRAL CATHETER

    MDR report key: 1526147 · Received November 10, 2009

    Report

    Report Number
    1710034-2009-00199
    Event Type
    Other
    Date Received
    November 10, 2009
    Date of Event
    January 1, 2009
    Report Date
    October 17, 2009
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE REPORTER AND AT THIS TIME NONE HAS BEEN RECEIVED. RESULTS: A REVIEW OF THE DEVICE HISTORY RECORD AND MATERIAL REVIEW REPORT WAS COMPLETED AND NO ABNORMALITIES OR IRREGULARITIES WERE FOUND DURING THE MANUFACTURE OF THE LOT NUMBER. RECEIVED ONE USED 1.9 FR WAS RECEIVED FOR ANALYSIS. THE RETURNED UNIT WAS RECEIVED IN THREE PIECES. PORTION 1 CONSISTED OF THE LUER/HUB; CATHETER TUBING WAS OVER THE BUSHING WITHIN THE LUER. THE TUBING HAD A SLIGHTLY JAGGED BREAK AND THE SMALL CRACKS WERE PRESENT ON THE LUER. PORTION 2 WAS THE LAVENDER STRAIN RELIEF; NO DAMAGE WAS NOTED TO THIS PORTION. PORTION 3 CONSISTED OF CATHETER TUBING APPROXIMATELY 31.3 CM IN LENGTH. THE AREA OF SEPARATION HAD DAMAGED, JAGGED UNEVEN EDGES WITH A SLIGHT FLARING PRESENT. CONCLUSIONS: THE ENGINEER CONFIRMED THAT AREA OF SEPARATION EXHIBITED JAGGED UNEVEN EDGES AND A SLIGHT FLARING. THE DAMAGE PRESENT IS CHARACTERISTIC OF A SEPARATION CAUSED BY STRESS TO THE CATHETER. L-CATH CATHETERS ARE 100 PERCENT PRESSURE TESTED (FLOW/LEAK) TO INSURE THE CATHETER HAS NO LEAKS OR OCCLUSIONS PRIOR TO ACCEPTANCE. A PULL TEST IS PERFORMED PER THE SPECIFICATIONS TO INSURE CATHETER STRENGTH AND INTEGRITY. PER THE MANUFACTURING SPECIFICATION A CONTROLLED STRAIN RELIEF TENSILE TEST SAMPLE IS TESTED FOR STRAIN RELIEF TO BUSHING TENSILE STRENGTH FOR THIS SPECIFIC GAUGE. (B)(4).

    Description of Event or Problem · 1

    CATHETER SEPARATED FROM THE STRAIN RELIEF AND THE STRAIN RELIEF PULLED OUT OF ADAPTER.

    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 9006527

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other