BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L-CATH PICC SINGLE LUMEN 28GA (1.2F) X 25CM

    MDR report key: 10390785 · Received August 11, 2020

    Report

    Report Number
    1625425-2020-00472
    Event Type
    Malfunction
    Date Received
    August 11, 2020
    Date of Event
    June 21, 2020
    Report Date
    August 7, 2020
    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 Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    FOLLOW UP.

    Additional Manufacturer Narrative · 1

    THE DEVICE USED IS INDICATED AS AVAILABLE FOR EVALUATION. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN RETURNED. A FOLLOW-UP REPORT WILL BE PROVIDED ONCE THE SAMPLE IS RECEIVED AND REVIEWED.

    Description of Event or Problem · 1

    WHEN CHANGING THE MICRO-CLAVE AND EXTENDING THE PICC-LINE THE PICC-LINE HUB BROKE. GRM 69861, LOT # 11278237. CONSEQUENCE: INCREASED RISK OF INFECTION, INSTALLATION OF A PIV AND THE INSTALLATION OF A NEW PICC-LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858700 L-CATH PICC SINGLE LUMEN 28GA (1.2F) X 25CM L-CATH PICC FOZ ARGON MEDICAL DEVICES 28 GA (1.2F) X 25CM 11278237 00886333209910

    Patients

    Seq Age Sex Outcome Treatment
    1 Other