BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDLINE INDUSTRIES, INC.

    MDR report key: 19369937 · Received May 22, 2024

    Report

    Report Number
    19369937
    Event Type
    Other
    Date Received
    May 22, 2024
    Date of Event
    December 6, 2023
    Report Date
    February 13, 2024
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    CAI
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DIFFICULT MASK VENTILATION REQUIRING ORAL AIRWAY AND THREE HANDS FOR MASK FIT. DIFFICULT DUE TO FAULTY DESIGN OF CIRCUIT MASK. PATIENT NOT A DIFFICULT MASK VENTILATION DUE TO ANATOMY (MASK VENTILATION AFTER EXTUBATION WITH THE OLD MASK WE HAD NO ISSUE WITH MASK VENTILATING WITH THE PRIOR SUPPLIED MASK). HAVING REPEATED ISSUES MASKING WITH THE NEW MASKS. MASKS ARE DANGEROUS AND NOT DESIGNED PROPERLY. ANESTHESIA QUALITY AND SHE INVESTIGATED THIS AND REPORTED BACK THAT THE NEW CIRCUITS AND MASKS ARRIVED AROUND THREE WEEKS AGO. SINCE ARRIVAL, MULTIPLE ISSUES HAVE OCCURRED AT MULTIPLE SITES. THE ANESTHESIA TECH MANAGER IS WORKING WITH THE MANUFACTURER TO GET A DIFFERENT PRODUCT AS THESE NEW MASKS ARE INFERIOR TO THE PREVIOUS PRODUCT THAT WAS STOCKED FOR YEARS. THEY ARE HOPING TO HAVE THIS RESOLVED SHORTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1749017 MEDLINE INDUSTRIES, INC. CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) CAI MEDLINE INDUSTRIES, INC. DYNJAAF6903 23HBY272

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown