BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Medline Industries, Inc.

    MDR report key: 14120550 · Received April 15, 2022

    Report

    Report Number
    1417592-2022-00053
    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
    CAH
    UDI-DI
    10080196893379
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY DURING A PROCEDURE THE BAG TO THE CIRCULATION HOSE TORE WHILE THE PATIENT WAS UNDER ANESTHESIA. PER THE FACILITY THE ANESTHESIOLOGIST NOTICED A DROP IN TIDAL VOLUME AND END TIDAL CO2 CAPNOGRAPHY. PER THE FACILITY THE ANESTHESIOLOGIST SWITCHED TO MANUAL VENTILATION AND HAD DIFFICULTY VENTILATING THE PATIENT, EVEN THOUGH THE PATIENT WAS 'SPONTANEOUSLY BREATHING WITHOUT DISTRESS OR INCREASE IN RESPIRATORY EFFORT. PER THE FACILITY AFTER 'SWITCHING TO AMBU BAG, AND CHANGING THE CIRCUIT EVERYTHING WENT BACK TO NORMAL'. THE SAMPLE WAS NOTED TO BE AVAILABLE, HOWEVER, IT WAS NOT RETURNED FOR EVALUATION. . 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 DURING A PROCEDURE THE BAG TO THE CIRCULATION HOSE TORE WHILE THE PATIENT WAS UNDER ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2174203 Medline Industries, Inc. PEDI ANESTH CIRCUIT,60"UNI,1BV,1L,GSL CAH MEDLINE INDUSTRIES LP DYNJAPF6002 22NBA728 10080196893379

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention