BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX WRAP STRAP ENDOTRACHEAL TUBE HOLDER

    MDR report key: 18488247 · Received January 10, 2024

    Report

    Report Number
    3008818980-2024-00001
    Event Type
    Malfunction
    Date Received
    January 10, 2024
    Date of Event
    December 1, 2023
    Report Date
    September 20, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BTR
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    QA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN, NO INFORMATION HAS BEEN PROVIDED TO DATE. E1 INITIAL REPORTER PHONE NUMBER: (B)(6). H3 - OTHER: DEVICE HAS NOT BEEN RETURNED TO DATE. 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.

    Description of Event or Problem · 0

    GCM RECEIVED AN EMAIL VIA SERVICE CLOUD ON 12-DECEMBER-2023 FROM EDUARD CHAVARRIA, BEHZAD PHARMACY, REGARDING A WRAP STRAP ET TUBE HOLDER NS + 100/CA WITH LOT NUMBER 2143303 SN. IT WAS STATED THAT THERE WAS NO MANUFACTURING AND EXPIRY DATE ON THE LABEL. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED. LMONTALBAN14-DEC-2023 UPDATE: GCM RECEIVED AN EMAIL ON 8-FEB-2024 STATING THAT THERE IS NO FAULT OF THE PRODUCT, NOR IT IS DEFECTED. THE ONLY ISSUE IS THERE IS NO MANUFACTURING DATE AND EXPIRY DATE SHOWN ON THE LABEL WHICH THE CUSTOMER REFUSED TO ACCEPT AT THE TIME OF DELIVERY IN THEIR WAREHOUSE. LMONTALBAN (B)(6) 2024

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS NO "MANUFACTURING AND EXPIRY DATES" ON THE LABEL. A PICTURE OF THE OUTER BOX WAS PROVIDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689872 PORTEX WRAP STRAP ENDOTRACHEAL TUBE HOLDER TUBE, TRACHEAL (W/WO CONNECTOR) BTR SMITHS MEDICAL ASD, INC. 2143303

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown