BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE LARYNGEAL TUBE, DUAL LUMEN

    MDR report key: 19330959 · Received May 16, 2024

    Report

    Report Number
    3012307300-2024-03756
    Event Type
    Malfunction
    Date Received
    May 16, 2024
    Date of Event
    April 14, 2024
    Report Date
    June 21, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BTR
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: EXPIRATION DATE AND H4: MANUFACTURE DATE ARE UNKNOWN, NO INFORMATION IS AVAILABLE BASED ON REPORTED LOT NUMBER. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION CODES: UPDATED. INVESTIGATION SUMMARY: THE RETURNED TUBE WAS FOUND IN GOOD CONDITION AND DISCOLORED TO PINK. THE PACKAGE WAS OPENED. VISUAL INSPECTION WAS PERFORMED. THE CUSTOMER'S INDICATED FAILURE WAS CONFIRMED. NO OTHER ANOMALY WAS OBSERVED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT PRODUCT(S) WILL BE FORWARDED TO THE MANUFACTURER/SUPPLIER (VBM MEDIZINTECHNIK GMBH) TO REQUEST A DETAILED INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWS THERE WERE NO OBSERVATIONS OR NONCONFORMITIES RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DISCOLORED TUBES WERE OBSERVED DURING INVENTORY INSPECTION. DISCOVERED UPON REMOVAL FROM PACKAGE, NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546899 DISPOSABLE LARYNGEAL TUBE, DUAL LUMEN TUBE, TRACHEAL (W/WO CONNECTOR) BTR SMITHS MEDICAL ASD, INC. 0000220537

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown