BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12062972 · Received June 24, 2021

    Report

    Report Number
    0001625425-2021-01014
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    June 9, 2021
    Report Date
    July 16, 2021
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    FOZ
    PMA / PMN Number
    K091670
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE RETURNED CATHETER FOUND A CRACKED HUB WHICH WOULD RESULT IN LEAKAGE, CONFIRMING THE COMPLAINT. CAPA C-2020-016 WAS PREVIOUSLY INITIATED TO ADDRESS THE PROBLEM, HOWEVER, THE CORRECTIVE ACTIONS IMPLEMENTED FAILED TO MITIGATE THE FAILURE. THE ROOT CAUSE INVESTIGATION HAS BEEN RE-OPENED WITH A NEW CAPA C-2021-039. THE CAPA WILL ALSO CAPTURE THE INITIATIVE TO IMPROVE THE PRODUCT DESIGN.

    Description of Event or Problem · 0

    2.6 FR ARGON DL PICC PLACED BY INTERVENTION RADIOLOGY ON (B)(6) 2021 IN RIGHT FEMORAL VEIN CATHETER TRIMMED TO 15.5 CM WITH NO EXTERNAL LENGTH. ON (B)(6) 2021 AT 1500 CRACK FOUND ALONG RED HUB WHERE NEEDLESS CONNECTOR ATTACHES PICC REMOVED AND NEW PICC INSERTED TO CONTINUE TREATMENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    2.6 FR ARGON DL PICC PLACED BY INTERVENTION RADIOLOGY ON (B)(6) 2021 IN RIGHT FEMORAL VEIN CATHETER TRIMMED TO 15.5 CM WITH NO EXTERNAL LENGTH. ON (B)(6) 2021 AT 1500 CRACK FOUND ALONG RED HUB WHERE NEEDLESS CONNECTOR ATTACHES PICC REMOVED AND NEW PICC INSERTED TO CONTINUE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961203 L-CATH PICC D/L 20GA (2.6F) 0.90MM X 60CM L-CATH PICC FOZ ARGON MEDICAL DEVICES 384466 11316041

    Patients

    Seq Age Sex Outcome Treatment
    1 Other