BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BUNNELL 2.5MM LIFEPORT ADAPTER

    MDR report key: 18703718 · Received February 14, 2024

    Report

    Report Number
    1719232-2024-00001
    Event Type
    Injury
    Date Received
    February 14, 2024
    Date of Event
    January 4, 2024
    Report Date
    February 7, 2024
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    PMA / PMN Number
    P850064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    USER FACILITY REPORT MW5150407 RECEIVED FROM FDA ON 02/01/2024. AT THIS TIME, THE USER FACILITY HAD NOT CONTACTED BUNNELL TO REPORT A COMPLAINT OR REQUEST RETURN AUTHORIZATION FOR THE PRODUCT. BUNNELL CLINICAL REPRESENTATIVE CONTACTED THE USER FACILITY TO ATTEMPT TO RECEIVE ADDITIONAL INFORMATION. BASED ON THIS CONVERSATION WITH THE USER FACILITY, IT DID NOT APPEAR THE BUNNELL LIFEPORT ITSELF RESULTED IN THE REPORTED INCIDENT. THE USER FACILITY WAS REQUESTED TO CONTACT BUNNELL'S HOTLINE IF ADDITIONAL ISSUES RECURRED. THE USER FACILITY HAD ALREADY DISPOSED OF THE SUSPECT DEVICE. THEREFORE, NO INVESTIGATION OF THE DEVICE WAS POSSIBLE. RETAIN SAMPLES FOR THE REPORTED LOT NUMBER (23043166) WERE EVALUATED, WITH NO PHYSICAL ABNORMALITIES NOTED. THEREFORE, CONNECTION TO THE ET TUBE SHOULD BE AS NORMALLY OBSERVED. COMPLAINT RECORDS WERE EVALUATED. THERE HAVE BEEN ZERO REPORTS OF ANY OTHER ISSUES, OF ANY KIND, ASSOCIATED WITH LOT NUMBER 23043166. ADDITIONALLY, WHEN 3 YEARS OF INVESTIGATION RECORDS WERE REVIEWED, THERE HAVE BEEN NO OTHER REPORTS OF LIFEPORT ADAPTERS DISCONNECTING FROM THE ET TUBE.

    Description of Event or Problem · 0

    AS REPORTED IN USER FACILITY REPORT MW5150407: "PATIENT ON A HIGH FREQUENCY JET VENTILATOR WITH ENDOTRACHEAL TUBE ADAPTER CONTINUOUSLY POPPING OFF FROM SITE CAUSING OPENING OF SYSTEM. PATIENT REQUIRED REINTUBATION AND NEW TUBING SYSTEM... PATIENT NOW POSITIVE FOR KLEBSIELLA OXYTOCA, COLLECTED FROM ENDOTRACHEAL ASPIRATION..." THE USER FACILITY DID NOT CONTACT BUNNELL TO INITIATE AN INVESTIGATION OR RETURN THE SUSPECT DEVICE. BUNNELL CLINICAL REPRESENTATIVE CONTACTED USER FACILITY FOR ADDITIONAL INFORMATION. THE USER FACILITY WAS REQUESTED TO CALL BUNNELL'S HOTLINE IF THIS IS A REOCCURRING ISSUE AND KEEP PACKAGING TO TRACK ANY LOT NUMBERS INVOLVED. BUNNELL'S CLINICAL REPRESENTATIVE WAS TOLD THE USER FACILITY HAS NOT HAD OTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1389803 BUNNELL 2.5MM LIFEPORT ADAPTER 2.5MM LPA LSZ BUNNELL, INC. 23043166

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other