BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VYNTUS

    MDR report key: 11016345 · Received December 16, 2020

    Report

    Report Number
    9615102-2020-00117
    Event Type
    Malfunction
    Date Received
    December 16, 2020
    Date of Event
    August 13, 2018
    Report Date
    November 24, 2020
    Manufacturer
    VYAIRE MEDICAL GMBH
    Product Code
    BZC
    UDI-DI
    14250892901432
    PMA / PMN Number
    K150810
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: D9 - DATE DEVICE RETURNED TO MANUFACTURER. VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). DEVICE EVALUATION: D9, G3, G6, H2, H10. THE COMPONENT WAS VISUALLY INSPECTED. IT WAS RECOGNIZED THAT THE WHITE TUBE HAD FALLEN OUT AND WAS NOT ATTACHED. INSPECTION SHOWED THAT THE WHITE TUBE WAS NOT GLUED CORRECTLY. PATIENT RISK TO SWALLOW THE PLASTIC PART IS VERY LIMITED BECAUSE THE DVT IS INSERTED IN A FACE MASK. THE RISK FOR A PATIENT TO SWALLOW THE PART IS VERY LOW AS IT WOULD DROP AND REST IN THE MASK. ADDITIONALLY, IN THE CASE OF A SPIROMETRY WITHOUT A MASK, A MICROGARD II FILTER MUST BE USED WHICH IS DIRECTLY CONNECTED BETWEEN THE PATIENT AND THE DVT. IT WAS DETERMINED THAT THE ROOT CAUSE FOR THE REPORTED ISSUE WAS THE WHITE TUBE WAS NOT GLUED CORRECTLY. THE MANUFACTURER WAS UNABLE TO DETERMINE A REASON AS TO WHY THE WHITE TUBE WAS NOT GLUED CORRECTLY.

    Additional Manufacturer Narrative · 1

    (B)(4). AT THIS TIME, VYAIRE HAS RECEIVED THE SUSPECT DEVICE/COMPONENT FOR EVALUATION. IT WAS FOUND THAT THE EXCHANGE BROKEN CONNECTOR AT SAMPLE LINE. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VYAIRE THAT THE LITTLE CLEAR TUBE AT THE END OF THE TWINTUBE COLLECTION SAMPLE LINE BROKE OFF. THIS IS CLOSE TO THE PATIENT'S FACE, WHERE THEY ARE BREATHING THROUGH A MASK. THERE IS RISK OF PART BEING ASPIRATED OR INGESTED. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1483548 VYNTUS TWINTUBE COLLECTION TUBE BZC VYAIRE MEDICAL GMBH TWINTUBE SAMPLE LINE 240CM 14250892901432

    Patients

    Seq Age Sex Outcome Treatment
    1