BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAR

    MDR report key: 20038021 · Received August 22, 2024

    Report

    Report Number
    2936999-2024-01340
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    July 30, 2024
    Report Date
    August 21, 2024
    Manufacturer
    MALLINCKRODT DAR SRL
    Product Code
    CAH
    UDI-DI
    20884522039649
    PMA / PMN Number
    K941381
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, THE PATIENT BECAME UNWELL IMMEDIATELY AFTER THE EXCHANGE OF FILTER AND RINGED FITTING. A LEAK WAS ALSO NOTED WITH THE BAG VALVE MASK. RESPIRATORY FAILURE WAS MANAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25933 DAR FILTER, BACTERIAL, BREATHING-CIRCUIT CAH MALLINCKRODT DAR SRL 352/5877 24B0328FAX 20884522039649

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other