BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AINTREE INTUBATION CATHETER

    MDR report key: 24277507 · Received February 6, 2026

    Report

    Report Number
    1820334-2026-00129
    Event Type
    Malfunction
    Date Received
    February 6, 2026
    Date of Event
    February 2, 2026
    Report Date
    February 6, 2026
    Manufacturer
    COOK INC
    Product Code
    BSR
    UDI-DI
    00827002576261
    PMA / PMN Number
    K162729
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D2A - COMMON DEVICE NAME: ADDITIONAL NAMES: BTR; TUBE, TRACHEAL (W/WO CONNECTOR). D2B - PRODUCT CODE: ADDITIONAL PRODUCT CODES: BTR. H3 - DEVICE EVALUATED BY MFG?: DEVICE EVALUATION ANTICIPATED BUT HAS NOT YET BEGUN. AWAITING DEVICE RETURN. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A HAIR-LIKE FIBER WAS FOUND WITHIN THE SEALED PACKAGING OF AN AINTREE INTUBATION CATHETER. THE DEVICE WAS NOT USED. NO HARM HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336788 AINTREE INTUBATION CATHETER BSR; STYLET, TRACHEAL TUBE BSR COOK INC G57626 16897228 00827002576261

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown