BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA PROSEAL, REU, SIZE 3 (150030)

    MDR report key: 6910199 · Received October 3, 2017

    Report

    Report Number
    9681900-2017-00039
    Event Type
    Malfunction
    Date Received
    October 3, 2017
    Date of Event
    July 10, 2017
    Report Date
    September 15, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THE DEVICE WAS YELLOW DUE TO MULTIPLE USES. WHEN THE DEVICE WAS CONNECTED TO THE SYRINGE, THE SYRINGE WAS UNABLE TO BLOW AIR INTO THE DEVICE OR EXTRACT AIR. A BRAND NEW RETAINED SAMPLE WAS COMPARED TO THE RETURNED SAMPLE. IT WAS FOUND THAT THE ADAPTOR CAP OF THE CHECK VALVE WAS MISSING ON THE SAMPLE RETURNED FROM THE CUSTOMER. THE RETAINED SAMPLE WAS THEN SENT FOR SIMULATING THE PROCESS OF CONNECTING AND DISCONNECTING A SYRINGE FOR MORE THAN TEN CYCLES. NO DETACHED ADAPTOR CAP WAS OBSERVED IN THE SIMULATION. IT WAS DETERMINED THAT THE CHECK VALVE COMPONENT WAS PROBABLY DETACHED/BROKEN DUE TO HANDLING/WASHING/BRUSHING AFTER MULTIPLE USES. ONCE THE COMPONENT OF THE VALVE HAS BEEN BROKEN/DETACHED, THE VALVE CAN NO LONGER FUNCTION NORMALLY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVOLVED IN THIS COMPLAINT HAS NOT BEEN RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT. THE INVESTIGATION INTO THIS COMPLAINT IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THE VALVE PORT WAS BROKEN. ALLEGED ISSUE REPORTED AS FOUND DURING INSPECTION/FUNCTIONAL TESTING PRIOR TO PATIENT USE. CUSTOMER SUBMITTED PHOTOS WITH THE COMPLAINT FOR REVIEW. THERE WAS NOT REPORT OF PATIENT HARM OR DELAY IN THERAPY.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THE VALVE PORT WAS BROKEN. ALLEGED ISSUE REPORTED AS FOUND DURING INSPECTION/FUNCTIONAL TESTING PRIOR TO PATIENT USE. CUSTOMER SUBMITTED PHOTOS WITH THE COMPLAINT FOR REVIEW. THERE WAS NOT REPORT OF PATIENT HARM OR DELAY IN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691496 LMA PROSEAL, REU, SIZE 3 (150030) AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY CAE TELEFLEX MEDICAL SN:8WPACLX6

    Patients

    Seq Age Sex Outcome Treatment
    1