BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L-CATH

    MDR report key: 2792302 · Received October 12, 2012

    Report

    Report Number
    2792302
    Event Type
    Malfunction
    Date Received
    October 12, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 12, 2012
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    PRIOR TO PLACEMENT OF CATHETER THE CLINICIAN ATTEMPTED TO MEASURE AND CUT THE CATHETER TO LENGTH. DURING THE MEASUREMENT THE CLINICIAN NOTICED THAT THE INSCRIBED 1 CM RADIO-OPAQUE MARKINGS BEGAN TO SHORTEN NEAR THE END OF THE CATHETER. THE CLINICIAN NOTED THAT THE MARKS WERE SHORTER AT THE 10CM MARK AND THAT THE 20CM MARK WAS 0.5CM SHORTER THAN THE SCALE'S 20CM MARK. THE CLINICIAN EXCHANGED FOR ANOTHER PICC LINE THAT INDICATED CORRECT MARKINGS. NEW CATHETER TRIMMED AND PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L-CATH CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM LJS ARGON MEDICAL DEVICES 1.9 FR 24 G X 30 CM SINGLE LUMEN 11021047

    Patients

    Seq Age Sex Outcome Treatment
    1 *