BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11838528 · Received May 17, 2021

    Report

    Report Number
    0001625425-2021-00917
    Event Type
    Malfunction
    Date Received
    May 17, 2021
    Date of Event
    January 22, 2021
    Report Date
    April 20, 2021
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    FOZ
    UDI-DI
    00886333209910
    PMA / PMN Number
    K091670
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE DEVICE WAS RETURNED FOR REVIEW. A FUNCTIONAL TEST FOUND LEAKAGE THROUGH A CRACK IN THE HUB, CONFIRMING THE COMPLAINT. CAPA C-2020-016 HAS BEEN INITIATED TO IDENTIFY ROOT CAUSE AND CORRECTIVE ACTION. THE MOLDING PARAMETERS OF THESE HUBS WERE UPDATED TO MEET MANUFACTURERS SUGGESTED SETTINGS AND MOLD 501-05 CAVITY 4 HAD A NEW CORE PIN INSTALLED THAT CONTROLS ALL THE CRITICAL DIMENSIONS FOR THE INNER DIAMETER. THE CAPA IS IN THE EFFECTIVENESS CHECK STAGE.

    Additional Manufacturer Narrative · 0

    ONE DEVICE WAS RETURNED FOR REVIEW. A FUNCTIONAL TEST FOUND LEAKAGE THROUGH A CRACK IN THE HUB, CONFIRMING THE COMPLAINT. CAPA C-2020-016 HAS BEEN INITIATED TO IDENTIFY ROOT CAUSE AND CORRECTIVE ACTION. THE MOLDING PARAMETERS OF THESE HUBS WERE UPDATED TO MEET MANUFACTURERS SUGGESTED SETTINGS AND MOLD 501-05 CAVITY 4 HAD A NEW CORE PIN INSTALLED THAT CONTROLS ALL THE CRITICAL DIMENSIONS FOR THE INNER DIAMETER. THE INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 0

    CALLED TO PATIENTS BEDSIDE BECAUSE PICC DRESSING WAS WET. LINE FOUND TO BE LEAKING WHEN FLUSHED.

    Description of Event or Problem · 0

    CALLED TO PATIENTS BEDSIDE BECAUSE PICC DRESSING WAS WET. LINE FOUND TO BE LEAKING WHEN FLUSHED.

    Description of Event or Problem · 1

    CALLED TO PATIENTS BEDSIDE BECAUSE PICC DRESSING WAS WET. LINE FOUND TO BE LEAKING WHEN FLUSHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735524 L-CATH PICC S/L 28GA (1.2F) X 25CM 1 LUMEN L-CATH PICC FOZ ARGON MEDICAL DEVICES 384516 11308071 00886333209910

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention