BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX TRACHEAL TUBE CLEAR MURPHEY EYESOFT SEAL

    MDR report key: 25244561 · Received May 21, 2026

    Report

    Report Number
    3012307300-2026-05280
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Date of Event
    April 28, 2026
    Report Date
    May 21, 2026
    Manufacturer
    ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V
    Product Code
    BTR
    UDI-DI
    15019315022333
    PMA / PMN Number
    K790312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILLED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    AN EMAIL WAS RECEIVED REGARDING A SDE ENDOTRACHEALE, WITH ITEM NUMBER: 100 199 075 AND UNKNOWN LOT NUMBER. IT WAS STATED THAT THE CUFF DEFLATED WITHIN APPROXIMATELY 5 SECONDS DUE TO A DEFECTIVE ORANGE VALVE. THERE WAS PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524250 PORTEX TRACHEAL TUBE CLEAR MURPHEY EYESOFT SEAL TUBE, TRACHEAL (W/WO CONNECTOR) BTR ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V 15019315022333

    Patients

    Seq Age Sex Outcome Treatment
    1