BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA FLEXIBLE, REU, SIZE 3 (110030)

    MDR report key: 7906179 · Received September 25, 2018

    Report

    Report Number
    9681900-2018-00033
    Event Type
    Malfunction
    Date Received
    September 25, 2018
    Date of Event
    August 21, 2018
    Report Date
    September 5, 2018
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THE CONNECTOR WAS CLEAR. IT WAS ALSO NOTICED THAT THE ADAPTER CAP WAS MISSING FROM THE CHECK VALVE. WHEN THE DEVICE WAS CONNECTED TO THE SYRINGE, THE SYRINGE WAS UNABLE TO BLOW AIR INTO THE DEVICE OR EXTRACT AIR FROM IT. BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT IS CONFIRMED. THE CHECK VALVE COMPONENT WAS MOST LIKELY DETACHED DUE TO HANDLING/WASHING/BRUSHING AFTER MULTIPLE CYCLES OF RE-USE.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT ALLEGES THE DEVICE WILL NOT INFLATE OR DEFLATE. ALLEGED ISSUE REPORTED AS DETECTED PRIOR TO USE ON A PATIENT DURING INSPECTION/FUNCTIONAL TESTING.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THE DEVICE WILL NOT INFLATE OR DEFLATE. ALLEGED ISSUE REPORTED AS DETECTED PRIOR TO USE ON A PATIENT DURING INSPECTION/FUNCTIONAL TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748774 LMA FLEXIBLE, REU, SIZE 3 (110030) AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY CAE TELEFLEX MEDICAL SN:9HQAACXT

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE REPORTED.| NONE REPORTED.