BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Medline Industries, Inc.

    MDR report key: 14119178 · Received April 15, 2022

    Report

    Report Number
    1423395-2022-00011
    Event Type
    Injury
    Date Received
    April 15, 2022
    Date of Event
    March 21, 2022
    Report Date
    April 15, 2022
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    OJH
    UDI-DI
    10193489370737
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY DURING A PROCEDURE THE BREATHING BAG 'BLEW OFF THE ARM' REQUIRING VENTILATION AND AN ADDITIONAL DEVICE. PER THE FACILITY THE ANESTHESIOLOGIST 'WAS PUTTING THE PATIENT TO SLEEP AND AS SOON AS THEY GRABBED THE BREATHING BAG TO OXYGENATE, THE BAG BLEW OFF OF THE ARM'. THE STAFF PLACED AN OXYGEN MASK ON THE PATIENT WHEN THE PATIENT BEGAN DE-SATURATE. THE STAFF 'GRABBED AN ADDITIONAL CIRCUIT AND ATTACHED THE BREATHING BAG TO THE MACHINE'. PER THE STAFF ONCE THE BREATHING BAG WAS ATTACHED THE PATIENT BECAME STABLE. ACCORDING TO THE STAFF THE 'PLASTIC COUPLE THAT CONNECTS THE BAG TO THE BREATHING ARM WAS SPLIT'. A VISUAL INSPECTION OF THE DEVICE WAS PERFORMED AND CONFIRMED THE STATED ISSUE OF THE CONNECTOR SPLITTING. PER THE INVESTIGATION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PICTURES PROVIDED. NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE FACILITY THAT DURING A PROCEDURE THE BREATHING BAG 'BLEW OFF THE ARM' REQUIRING VENTILATION AND AN ADDITIONAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1906473 Medline Industries, Inc. EXTREMITY OJH MEDLINE INDUSTRIES LP DYNJ902595G 10193489370737

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention