BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20652335 · Received November 11, 2024

    Report

    Report Number
    0001625425-2024-01129
    Event Type
    Malfunction
    Date Received
    November 11, 2024
    Date of Event
    August 26, 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
    003

    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 WAS CONDUCTED, AND NO SIMILAR CONCERNS WERE FOUND. 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. ADDITIONAL INFORMATION PROVIDED IN H.6. AND H.11.

    Description of Event or Problem · 0

    LEAKING AT PURPLE HUB¿ DATE PICC INSERTED- ¿ON (B)(6) 2024¿. ¿84 DAYS OF DWELL TIME¿. ¿22 DRESSING CHANGES¿, ¿NI PICC¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1568297 L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM L-CATH PICC S/L LJS ARGON MEDICAL DEVICES 384539 11555037 00886333209934

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown