BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12536943 · Received September 27, 2021

    Report

    Report Number
    0001625425-2021-01086
    Event Type
    Malfunction
    Date Received
    September 27, 2021
    Report Date
    October 7, 2021
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    LJS
    UDI-DI
    00886333209910
    PMA / PMN Number
    K091670
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    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

    1.2FR PICC LEAKING/CRACKING AT THE HUB. PICC REMOVED. NEW PICC PLACED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    1.2FR PICC LEAKING/CRACKING AT THE HUB. PICC REMOVED. NEW PICC PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1435498 L-CATH PICC S/L 28GA (1.2F) X 25CM 1 LUMEN) L-CATH PICC LJS ARGON MEDICAL DEVICES 384516 UNKNOWN 00886333209910

    Patients

    Seq Age Sex Outcome Treatment
    1 Other