BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHEST TUBE SYSTEM

    MDR report key: 22916452 · Received August 28, 2025

    Report

    Report Number
    MW5175376
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Date of Event
    August 22, 2025
    Report Date
    August 22, 2025
    Manufacturer
    TELEFLEX LLC (NADC)
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DOCTOR BROUGHT TO MY ATTENTION THAT OVER THE PAST SEVERAL MONTHS, PATIENTS WITH PERSISTENT AIR LEAKS IN THE TELEFLEX CHEST TUBE DRAINAGE SYSTEM HAVE SPONTANEOUSLY RESOLVED AFTER CHANGING THE DRAINAGE SYSTEM. DR. BELIEVES THIS COULD BE DUE TO MANUFACTURING DEFECT AS IT HAS BEEN OCCURRING THROUGHOUT THE HOSPITAL ON DIFFERENT FLOORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2223259 CHEST TUBE SYSTEM BOTTLE, COLLECTION, VACUUM KDQ TELEFLEX LLC (NADC) A-6000-08LF 74D2500649

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male