BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA CLASSIC, REU, SIZE 3 (100030)

    MDR report key: 7373139 · Received March 27, 2018

    Report

    Report Number
    9681900-2018-00022
    Event Type
    Malfunction
    Date Received
    March 27, 2018
    Date of Event
    January 25, 2018
    Report Date
    March 7, 2018
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER REPORTS THE DEVICE HAD BE RE-PROCESSED 19 TIMES. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THE CUFF WAS DEFORMED. THE CHECK VALVE WAS INSPECTED AND WAS FOUND TO BE FUNCTIONING PROPERLY. NO BLOCKAGES WERE FOUND. 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 KNOWN TO LEAD TO CUFF HERNIATION. DURING HIGH TEMPERATURE, VACUUM, AND HUMID AUTOCLAVING ENVIRONMENT, ANY AIR/MOISTURE LEFT INSIDE THE CUFF WILL EXPAND SIGNIFICANTLY AND WILL BADLY IMPACT THE PROPERTIES OF THE DEVICE TO AN IRREPARABLE CONDITION. IT IS SUSPECTED THAT SOME RESIDUAL AIR/MOISTURE WAS LEFT INSIDE THE DEVICE WHILE HANDLING THAT CAUSED THE FAILURE INADVERTENTLY. THE CUFF MUST ALSO BE COMPLETELY DEFLATED PRIOR TO AUTOCLAVING.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "WHEN INSUFFLATING, THE DISTAL PART OF THE MASK'S BALLON PRESENTS A BIGGER DILATION AND DETERIORATION OF THE MATERIAL IN ITS ELASTICITY. IT IS INSUFFLATED WITH 20 ML OF AIR, SHOWING WEAKNESS OF THE MATERIAL, WICH IS MORE LAX AND INSUFFLATES MUCH MORE OF WHAT SHOULD BE." ALLEGED ISSUE REPORTED AS DETECTED PRIOR TO A PATIENT USE DURING FUNCTIONAL TESTING. THERE WAS NO REPORT OF PATIENT IMPACT OR CONSEQUENCE.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "WHEN INSUFFLATING, THE DISTAL PART OF THE MASK'S BALLOON PRESENTS A BIGGER DILATION AND DETERIORATION OF THE MATERIAL IN ITS ELASTICITY. IT IS INSUFFLATED WITH 20 ML OF AIR, SHOWING WEAKNESS OF THE MATERIAL, WHICH IS MORE LAX AND INSUFFLATES MUCH MORE OF WHAT SHOULD BE." ALLEGED ISSUE REPORTED AS DETECTED PRIOR TO A PATIENT USE DURING FUNCTIONAL TESTING. THERE WAS NO REPORT OF PATIENT IMPACT OR CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215531 LMA CLASSIC, REU, SIZE 3 (100030) AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY CAE TELEFLEX MEDICAL SN:82QAEJD3

    Patients

    Seq Age Sex Outcome Treatment
    1