BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAR

    MDR report key: 20122291 · Received September 2, 2024

    Report

    Report Number
    2936999-2024-01382
    Event Type
    Injury
    Date Received
    September 2, 2024
    Date of Event
    June 3, 2024
    Report Date
    September 2, 2024
    Manufacturer
    MALLINCKRODT MEDICAL
    Product Code
    BSY
    UDI-DI
    20884522035207
    PMA / PMN Number
    K031997
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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, THERE WAS AN AIR LEAK OBSERVED BETWEEN TUBE AND VENTILATOR HOSES. A CRACKED ON THE WHITE TIP (SIDE OF THE RINGED CONNECTOR THAT GOES TO THE VENTILATOR HOSES) WAS ALSO FOUND. THE PATIENT HAD DESATURATION WITH HYPOXIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006475 DAR CATHETERS, SUCTION, TRACHEOBRONCHIAL BSY MALLINCKRODT MEDICAL 444SP02014 20884522035207

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening