BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA PROSEAL, REU, SIZE 5

    MDR report key: 6096392 · Received November 11, 2016

    Report

    Report Number
    9681900-2016-00049
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Date of Event
    November 4, 2016
    Report Date
    November 4, 2016
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ROOT CAUSE WAS RE-EVALUATED: THE MANUFACTURING PROCESS WAS REVIEWED AND WAS BEING DONE CORRECTLY BY ALL OPERATORS AND AS PER DOCUMENTED PROCEDURE. THE ROOT CAUSE IS NOT DUE TO A MANUFACTURING DEFECT AS THE PROBLEM COULD BE DUE TO THE CLEANING METHODOLOGY BY THE USER AFTER MULTIPLE USES.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE. THE USED DEVICE WAS NOT RECEIVED IN THE ORIGINAL TELEFLEX LMA PACKAGING. THE CONNECTOR WAS OBSERVED TO BE CLEAR. THE DEVICE WAS INFLATED AND WAS OBSERVED TO BE UNABLE TO HOLD INFLATION. THE FAILURE LOCATION WAS IDENTIFIED WHEN THE DEVICE WAS IMMERSED INTO WATER WHILE BEING INFLATED. THE REPORTED COMPLAINT WAS CONFIRMED AND THERE WAS A PINHOLE FOUND BETWEEN THE JOINT OF THE INFLATION LINE AND THE CUFF SPIGOT WHICH RESULTED IN A LEAK. IT IS PROBABLE THAT AN AIR BUBBLE WAS PRESENT THAT BURST DURING INFLATION AND CREATED A PINHOLE. OPERATORS WERE MADE AWARE OF THE INCIDENT AND REMINDED OF THE IMPORTANCE OF FOLLOWING THE PROCEDURES. THERE WILL BE CONTINUED MONITORING/TRENDING OF SIMILAR INCIDENTS TO CONFIRM IF ADDITIONAL ACTIONS WILL BE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THE DEVICE LEAKED AFTER INTUBATION. THERE WAS NO PATIENT HARM REPORTED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THE DEVICE LEAKED AFTER INTUBATION. THERE WAS NO PATIENT HARM REPORTED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THE DEVICE LEAKED AFTER INTUBATION. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746772 LMA PROSEAL, REU, SIZE 5 LARYNGEAL MASK AIRWAY CAE TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1