BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L-CATH S/L 28 GA

    MDR report key: 5142132 · Received October 9, 2015

    Report

    Report Number
    1625425-2015-00055
    Event Type
    Malfunction
    Date Received
    October 9, 2015
    Date of Event
    September 9, 2015
    Report Date
    October 9, 2015
    Manufacturer
    ARGON MEDICAL DEVICES, INC.
    Product Code
    LJS
    PMA / PMN Number
    K920755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO SERIOUS INJURY TO THE PATIENT. THE SPLITTABLE NEEDLE WOULD NOT SPLIT AND THE NEEDLE AND CATHETER HAD TO BE REMOVED AND REPLACED WITH A NEW ONE. NO DISCREPANCIES WERE NOTED IN THE DEVICE HISTORY RECORD. ACCORDING TO THE COMPLAINT FORM, THE COMPLAINT WAS NOT AVAILABLE FOR RETURN. THE COMPLAINT SAMPLE WAS NOT RETURNED FOR ANALYSES; THEREFORE A DEFINITIVE ROOT CAUSE OF THE NEEDLES NOT SPLITTING WAS NOT DETERMINED. NO OTHER SIMILAR COMPLAINTS WERE FOUND FOR THIS LOT.

    Description of Event or Problem · 1

    TWO NEEDLES FROM THE SAME LOT FAILED TO SEPARATE WHEN CRACKED. BOTH CATHETERS NEEDED TO BE REMOVED SINCE THEY COULD NOT SEPARATE THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671137 L-CATH S/L 28 GA L-CATH PICC LJS ARGON MEDICAL DEVICES, INC. 111000329

    Patients

    Seq Age Sex Outcome Treatment
    1