BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITAL SIGNS BREATHING CIRCUITS, EXPANDABLE, ADULT, DISPOSABLE, 1.8 M/72 IN

    MDR report key: 18727890 · Received February 16, 2024

    Report

    Report Number
    3010838917-2024-00105
    Event Type
    Malfunction
    Date Received
    February 16, 2024
    Date of Event
    January 24, 2024
    Report Date
    February 16, 2024
    Manufacturer
    VYAIRE MEDICAL OY
    Product Code
    CAI
    UDI-DI
    10190752136694
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE FILE IDENTIFICATION: (B)(4). H3: 81 OTHER ¿ AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE HAS NOT BEEN DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE. H3 OTHER TEXT : DEVICE NOT RETURNED YET.

    Additional Manufacturer Narrative · 0

    VYAIRE FILE IDENTIFICATION: (B)(4). AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE HAS NOT BEEN DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITION INFORMATION BECOMES AVAILABLE. ISSUE WAS CONFIRMED BASED ON THE PICTURE PROVIDED BY THE CUSTOMER. BASED ON THE PICTURE IT IS CLEAR THAT THE TUBE HAS BEEN DAMAGED. IT IS HOWEVER NOT POSSIBLE TO DETERMINE AT WHICH POINT THIS DAMAGE HAS OCCURRED. IT IS ALSO NOT POSSIBLE TO DETERMINE IF THE DAMAGE GOES THROUGH THE PRODUCT CAUSING THE LEAK, BUT THIS IS POSSIBLE. PRODUCTION PROCESS INCLUDES LEAK TEST THAT WOULD CATCH A LEAKING PRODUCT. THEREBY IT IS VERY UNLIKELY THAT THE DAMAGE WOULD HAVE BEEN CAUSED DURING PRODUCTION. THE MOST LIKELY CAUSE OF THE DAMAGE IS ROUGH HANDLING OF THE PRODUCT PACKAGE, OR ROUGH HANDLING OF THE PRODUCT BY THE USER.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE CIRCUIT E(A) 1.8M 1.5M-EXT 2L BAG GSE HAVE LEAKS. FURTHERMORE, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE CIRCUIT E(A) 1.8M 1.5M-EXT 2L BAG GSE HAVE LEAKS. FURTHERMORE, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1085641 VITAL SIGNS BREATHING CIRCUITS, EXPANDABLE, ADULT, DISPOSABLE, 1.8 M/72 IN CIRCUIT, BREATHIG (W CONNECTOR, ADAPTER, Y PIECE) CAI VYAIRE MEDICAL OY M1090619 230804 10190752136694

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other