BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L-CATH¿ PICC S/L 28GA (1.2F) 0.40MM X 25CM

    MDR report key: 21388127 · Received February 14, 2025

    Report

    Report Number
    0001625425-2025-00939
    Event Type
    Malfunction
    Date Received
    February 14, 2025
    Date of Event
    December 6, 2024
    Report Date
    May 9, 2025
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    LJS
    PMA / PMN Number
    K091670
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 MANUFACTURING AND INSPECTION RECORDS FOR THE PROVIDED LOT WAS CONDUCTED. NO DEVIATIONS OR NON-CONFORMANCES WERE FOUND. ACCORDING TO THE PRODUCT EXPERIENCE REPORT, THERE WAS NO SAMPLE AVAILABLE TO RETURN FOR REVIEW. ADDITIONALLY, THERE WAS NO VISUAL EVIDENCE PROVIDED TO SUPPORT THE ALLEGED COMPLAINT. WITHOUT SUCH EVIDENCE, A THOROUGH INVESTIGATION COULD NOT BE CONDUCTED TO ESTABLISH A DEFINITE ROOT CAUSE AND AN APPROPRIATE CORRECTIVE ACTION. IF THE SAMPLE IS RETURNED AT A FUTURE DATE, THIS COMPLAINT MAY BE REOPENED FOR FURTHER EVALUATION AT THAT TIME.

    Description of Event or Problem · 0

    ¿BOTH LEAK & OCCLUSION¿ ¿AT HUB¿ ¿LINE CONTINUED TO FUNCTION¿ DURATION: ¿<12HRS¿ CONTINUOUS INFUSIONS: ¿NS W/ AT 1.5, PROSTAGLANDIN¿ MEDICATIONS: NOTES: ¿28G PICC BEEPED OFF OCCLUDED PATIENT SIDE AT 0315. RN TROUBLESHOOTED AND COULDN'T GET LINE TO RUN APPROPRIATELY. NRN FLUSHED LINE AND FOUND THAT LINE WAS LEAKING WHERE MICROTUBING MET PICC HUB. NP CALLED TO BEDSIDE. MICROTUBING WAS REMOVED, PICC WAS UNDRESSED AND FLUSHED AT HUB AND FOUND TO BE FLUSHING APPROPRIATELY. NEW MICROTUBING AND MICROCLAVE WERE APPLIED. PICC WAS STERILELY REDRESSED.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1624426 L-CATH¿ PICC S/L 28GA (1.2F) 0.40MM X 25CM CATHETER, INTRAVASCULAR, THERAPEUTIC LJS ARGON MEDICAL DEVICES 384540 11572887

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown