BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM

    MDR report key: 20666823 · Received November 12, 2024

    Report

    Report Number
    0001625425-2024-01143
    Event Type
    Malfunction
    Date Received
    November 12, 2024
    Date of Event
    August 19, 2024
    Report Date
    March 21, 2025
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    LJS
    UDI-DI
    00886333209934
    PMA / PMN Number
    K091670
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE IS NOT AVAILABLE FOR RETURN. THE INVESTIGATION IS CURRENTLY IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON INVESTIGATION COMPLETION.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DHR AND INSPECTION RECORDS COULD NOT BE CONDUCTED, SINCE A LOT NUMBER WAS NOT PROVIDED. ACCORDING TO THE CUSTOMER, THERE WERE NO SAMPLES AVAILABLE FOR REVIEW. ADDITIONALLY, THERE WAS NO VISUAL EVIDENCE PROVIDED TO SUPPORT THE ALLEGED COMPLAINT. WITHOUT SUCH EVIDENCE, THE RESULTS ARE INCONCLUSIVE AND THE COMPLAINT COULD NOT BE CONFIRMED. WITHOUT SUCH EVIDENCE, THE RESULTS ARE INCONCLUSIVE AND THE COMPLAINT COULD NOT BE CONFIRMED. ESTABLISHING A ROOT CAUSE AND APPROPRIATE CORRECTIVE ACTION FOR THE REPORTED ISSUE IS NOT POSSIBLE.

    Description of Event or Problem · 0

    DATE OF INSERTION ¿ (B)(6) 2024: 46 DAYS DWELL TIME. 7 DRESSING CHANGES. ASSESSING DRSGS, FOUND WET. REMOVED DRSG AND NOTICED TPN/LIPIDS LEAKING FROM WHERE THE LINE ENTERS THE PURPLE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975790 L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM L-CATH PICC LJS ARGON MEDICAL DEVICES 384539 UNK 00886333209934

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown