BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROGUARD IIB FILTER KIT

    MDR report key: 6720318 · Received July 17, 2017

    Report

    Report Number
    8030673-2017-00355
    Event Type
    Malfunction
    Date Received
    July 17, 2017
    Date of Event
    June 29, 2017
    Report Date
    July 17, 2017
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    BXJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). (B)(4). AT THIS TIME, CAREFUSION HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    AN END USER REPORTED TO VYAIRE MEDICAL THAT A NOSE CLIP BROKE WHEN BEING SQUEEZED FOR PLACEMENT ON A PATIENT AND THE END USER WAS STRUCK IN THE FACE BY ONE HALF OF THE NOSE CLIP WHEN IT BROKE. THE END USER REPORTED THAT THEY RECEIVED A SCRATCH AS A RESULT OF BEING HIT IN THE FACE WITH THE BROKEN CLIP BUT DID NOT SEEK MEDICAL TREATMENT. THERE WAS NO IMPACT TO PATIENTS ASSOCIATED WITH THE PROBLEM REPORTED TO VYAIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500162 MICROGUARD IIB FILTER KIT CLIP, NOSE BXJ VYAIRE MEDICAL, INC MICROGARD IIB FILTER KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other