BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST PICC

    MDR report key: 2441766 · Received February 3, 2012

    Report

    Report Number
    1625425-2012-00013
    Event Type
    Malfunction
    Date Received
    February 3, 2012
    Date of Event
    January 12, 2012
    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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FAILURE COULD NOT BE VERIFIED DUE TO NO PRODUCT BEING RETURNED FOR EVAL. A ROOT CAUSE IS UNABLE TO BE DETERMINED; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN. IF PRODUCT IS RETURNED IN THE FUTURE, THE ISSUE WILL BE REEVALUATED AT THAT TIME.

    Description of Event or Problem · 1

    THE LINE WAS NOT PLACED IN THE PT YET. THE NURSE PRACTIONER WAS GETTING READY TO PLACE THE LINE. SHE FLUSHED IT WITH A 10CC SYRINGE AND NOTICED THAT IT WAS LEAKING. SHE THEN PICKED UP THE LINE TO LOOK AT THE LEAK AND IT SNAPPED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other