BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 21425805 · Received February 20, 2025

    Report

    Report Number
    0001625425-2025-00949
    Event Type
    Injury
    Date Received
    February 20, 2025
    Date of Event
    December 28, 2024
    Report Date
    February 20, 2025
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    LJS
    UDI-DI
    00886333221288
    PMA / PMN Number
    K091670
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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 INDICATED AS AVAILABLE FOR RETURN. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN RETURNED. A FOLLOW-UP REPORT WILL BE PROVIDED ONCE THE DEVICE HAS BEEN RECEIVED AND REVIEWED.

    Description of Event or Problem · 0

    ¿LEAK AT HUB AND UNDER DRESSING. LINE HAD TO BE PULLED. AFTER LINE REMOVED, NO LEAKING NOTED AT HUB. DURATION: ¿8HRS¿. CONTINUOUS INFUSIONS: ¿NVN AT 8.5, LIPIDS AT 1¿. MEDICATIONS: ¿AMPICILLIN, GENTAMICIN, AND CAFFEINE¿. NOTES: ¿WHEN NURSE WENT INTO PATIENT'S ROOM TO DO HER ASSESSMENT, THE SWADDLE WAS SOAKED. AFTER FURTHER ASSESSMENT, IT WAS NOTICED THE BURN NETTING WAS ALSO WET. THE NP WAS NOTIFIED AND CAME TO THE BEDSIDE. SHE FLUSHED THE PICC LINE AND THERE WAS LEAKING NOTED, COMING FROM THE PICC. IT WAS THEN REMOVED AND A NEW PICC LINE WAS INSERTED.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624765 L-CATH PICC S/L 28GA (1.2F) 0.40MM X 25CM CATHETER, INTRAVASCULAR, THERAPEUTIC LJS ARGON MEDICAL DEVICES 384540 11586169 00886333221288

    Patients

    Seq Age Sex Outcome Treatment
    1