BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST PICC

    MDR report key: 2441767 · Received February 3, 2012

    Report

    Report Number
    1625425-2012-00011
    Event Type
    Malfunction
    Date Received
    February 3, 2012
    Date of Event
    November 15, 2011
    Report Date
    January 26, 2012
    Manufacturer
    ARGON MEDICAL DEVICES, INC.
    Product Code
    FOZ
    PMA / PMN Number
    K944504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF DEVICE EVAL WILL BE FILED IN A SUPPLEMENTAL REPORT WHEN SAMPLE IS RECEIVED. ADD'L INFO REQUESTED NECESSARY IN DETERMINING REPORTABILITY. REQUESTED: 01/03/2012. RECEIVED: 01/17/2012.

    Description of Event or Problem · 1

    THE CATHETER WAS INSERTED ON (B)(6), WHEN DOING MAINTENANCE ON THE (B)(6) THE NURSE FOUND THAT LEAKAGE OVER THE DISC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST PICC FOZ ARGON MEDICAL DEVICES, INC. NA 0299918

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other