BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXAIR CAPR

    MDR report key: 25000129 · Received April 27, 2026

    Report

    Report Number
    MW5187295
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Date of Event
    April 17, 2026
    Report Date
    April 20, 2026
    Manufacturer
    SYNTECH DE BAJA CALIFORNIA, S DE RL DE CV.
    Product Code
    FYA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A POTENTIAL EXPOSURE TO A TUBERCULOSIS PATIENT OCCURRED AFTER A STAFF MEMBER USED A MAXAIR CAPR FOR RESPIRATORY PROTECTION AND SUBSEQUENTLY LEARNED THAT THE FILTER IN THE CAPR HAD EXCEEDED THE MANUFACTURER'S RECOMMENDED SHELF LIFE. ON (B)(6) 2026, A NURSE WHO USED ONE OF THE MAXAIR CAPRS CONTACTED THE MANUFACTURER TO INQUIRE ABOUT THE SHELF LIFE OF THE FILTERS AS THERE IS NO EXPIRATION DATE CONTAINED ON THE PRODUCT LABEL. THE MANUFACTURER RESEARCHED THE LOT NUMBER OF THE FILTER AND DETERMINED THAT THE FILTER USED WAS MANUFACTURED IN 2020. INFECTION PREVENTION WAS CONSULTED AND DEEMED THE STAFF MEMBER WAS AT RISK OF TB EXPOSURE. PLEASE REQUEST THAT THE MANUFACTURER INCLUDE AN EXPIRATION DATE FOR PROPER SUPPLY MANAGEMENT/ROTATION TO ENSURE PRODUCTS ON THE SHELF CAN BE EASILY ASSESSED FOR EXPIRATION DATES. THE MANUFACTURER STATES FILTERS HAVE A SHELF LIFE OF 5 YEARS HOWEVER THE PRODUCT LABEL ON THE FILTERS DOES NOT CONTAIN AN EXPIRATION DATE OR A MANUFACTURING DATE. THE MANUFACTURER DOES NOT PROVIDE EFFICACY DATA ON FILTERS USED BEYOND THE 5 YEAR SHELF LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48172 MAXAIR CAPR GOWN, SURGICAL FYA SYNTECH DE BAJA CALIFORNIA, S DE RL DE CV. 2180-05 FILTER 1811008

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown