BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON IN-LINE NEB TEE WITH VALVEM

    MDR report key: 5070329 · Received September 11, 2015

    Report

    Report Number
    1044475-2015-00337
    Event Type
    Malfunction
    Date Received
    September 11, 2015
    Date of Event
    July 16, 2015
    Report Date
    August 25, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BD
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND NO DEFECTS WERE FOUND. THE DEVICE WAS MEASURED AND WAS FOUND TO BE WITHIN SPECIFICATION. IT WAS ALSO FOUND THAT THE SPRING WORKED NORMALLY WHEN PRESSED. THE PRODUCT WAS MANUFACTURED IN 2011 AND THE EXPIRATION DATE WAS 2014. BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THERE WERE NO ISSUES WERE FOUND WITH THE RETURNED SAMPLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE SAMPLE WAS RECEIVED BY THE MANUFACTURER BUT THE INVESTIGATION IS INCOMPLETE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE SPRING IS MALFUNCTIONING AND CAUSING THE NEBULIZER TO POP OFF WHEN CONNECTED TO THE COMPRESSED AIR SUPPLY. NO PATIENT INJURY/HARM REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE SPRING IS MALFUNCTIONING AND CAUSING THE NEBULIZER TO POP OFF WHEN CONNECTED TO THE COMPRESSED AIR SUPPLY. NO PATIENT INJURY/HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603366 HUDSON IN-LINE NEB TEE WITH VALVEM VALVED TEE ADAPTOR CCQ TELEFLEX MEDICAL 110214

    Patients

    Seq Age Sex Outcome Treatment
    1