BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA CLASSIC, REU, SIZE 4 (100040)

    MDR report key: 8127346 · Received December 3, 2018

    Report

    Report Number
    9681900-2018-00042
    Event Type
    Malfunction
    Date Received
    December 3, 2018
    Date of Event
    November 6, 2018
    Report Date
    November 9, 2018
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THE INFLATION BALLOON OF THE COMPLAINT DEVICE WAS DAMAGED. THE SHAPE OF THE BALLOON LOOKED BIGGER THAN IT SHOULD BE. THE INFLATION BALLOON MATERIAL LOST ITS RESILIENCE DUE TO STRESS. IT IS CONSISTENT THAT THE INFLATION BALLOON WAS RUPTURED BY AIR. THE CHECK VALVE OF THE INFLATION BALLOON WAS FOUND TO BE FUNCTIONAL. THERE WAS NO BLOCKAGE ON THE CHECK VALVE AND AIR COULD BE INFLATED AND DEFLATED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT WAS CONFIRMED. OVER-INFLATION IS A KNOWN CAUSE THAT LEADS TO INFLATION BALLOON RUPTURE. DURING HIGH TEMPERATURE, VACUUM, AND HUMID AUTOCLAVING ENVIRONMENT, ANY AIR/MOISTURE TRAPPED INSIDE THE DEVICE WILL EXPAND SIGNIFICANTLY AND WILL DAMAGE THE PROPERTIES OF THE DEVICE TO AN IRREPARABLE CONDITION. IT IS SUSPECTED THAT THERE WAS SOME KIND OF RESIDUAL AIR/MOISTURE LEFT IN THE DEVICE WHILE RE-PROCESSING/HANDLING THAT CAUSE THE FAILURE INADVERTENTLY.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT ALLEGES THE PILOT BALLOON VALVE RUPTURED IN SECOND USE. ALLEGED DEFECT REPORTED DETECTED PRIOR TO USE ON A PATIENT. NO PATIENT HARM REPORTED. PATIENT CONDITION REPORTED AS FINE.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT ALLEGES THE PILOT BALLOON VALVE RUPTURED IN SECOND USE. ALLEGED DEFECT REPORTED DETECTED PRIOR TO USE ON A PATIENT. NO PATIENT HARM REPORTED. PATIENT CONDITION REPORTED AS FINE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THE PILOT BALLOON VALVE RUPTURED IN SECOND USE. ALLEGED DEFECT REPORTED DETECTED PRIOR TO USE ON A PATIENT. NO PATIENT HARM REPORTED. PATIENT CONDITION REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966750 LMA CLASSIC, REU, SIZE 4 (100040) AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY CAE TELEFLEX MEDICAL MFAAD9

    Patients

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