BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L-CATH PICC D/L 20GA (2.6F) 0.90MM X 60CM

    MDR report key: 12054027 · Received June 23, 2021

    Report

    Report Number
    0001625425-2021-01009
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    May 27, 2021
    Report Date
    June 2, 2021
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    LJS
    PMA / PMN Number
    K091670
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    117

    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 WILL CONTINUE TO INVESTIGATE ADDITIONAL ROOT CAUSES AND CORRECTIVE ACTIONS.

    Description of Event or Problem · 0

    PICC WAS PLACED L SAPHENOUS ON (B)(6) 2021 2.6 D/L L CATH- PICC STAFF CHANGE FLUID EVERY 24HRS. ON THE 9TH DAY, CLINICIAN NOTICED LEAKING & CONFIRMED THE BLUE HUB HAD A CRACK.

    Additional Manufacturer Narrative · 1

    SAMPLE WAS RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE A REVIEW OF THE SAMPLE HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PICC WAS PLACED L SAPHENOUS ON(B)(6) 20212.6 D/L L CATH- PICC STAFF CHANGE FLUID EVERY 24HRS. ON THE 9TH DAY, CLINICIAN NOTICED LEAKING & CONFIRMED THE BLUE HUB HAD A CRACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951808 L-CATH PICC D/L 20GA (2.6F) 0.90MM X 60CM L-CATH PICC LJS ARGON MEDICAL DEVICES 384466 11353814

    Patients

    Seq Age Sex Outcome Treatment
    1 Other