BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L-CATH PICC S/L 28GA (1.2F) X 25CM 1 LUMEN)

    MDR report key: 12781844 · Received November 9, 2021

    Report

    Report Number
    0001625425-2021-01117
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Report Date
    December 13, 2021
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    LJS
    UDI-DI
    00886333209910
    PMA / PMN Number
    K091670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SEVERAL COMPLAINTS HAVE PREVIOUSLY BEEN RECEIVED REGARDING A CRACKED HUB RESULTING IN LEAKAGE, AND CAPA 2021-039 HAS BEEN INITIATED TO ADDRESS THIS ISSUE AND IS CURRENTLY UNDER INVESTIGATION. THE CAPA WILL IDENTIFY THE SPECIFIC CAUSES AND CORRECTIVE ACTIONS TO BE TAKEN.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS INDICATED AS AVAILABLE FOR RETURN, AT THE TIME OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND EVALUATED.

    Description of Event or Problem · 0

    BROKEN PICC. LEAKING @ HUB.

    Description of Event or Problem · 0

    BROKEN PICC. LEAKING @ HUB¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1674693 L-CATH PICC S/L 28GA (1.2F) X 25CM 1 LUMEN) L-CATH PICC LJS ARGON MEDICAL DEVICES 384516 UNK 00886333209910

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other