BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA CLASSIC, REU, SIZE 4 (100040)

    MDR report key: 7278112 · Received February 16, 2018

    Report

    Report Number
    9681900-2018-00015
    Event Type
    Malfunction
    Date Received
    February 16, 2018
    Date of Event
    January 31, 2018
    Report Date
    February 5, 2018
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THE AIRWAY TUBE OF THE DEVICE WAS DISCOLORED DUE TO MULTIPLE USES. WHEN THE DEVICE WAS CONNECTED TO A SYRINGE, THE SYRINGE WAS UNABLE TO BLOW AIR INTO THE DEVICE OR EXTRACT AIR FROM THEM. THE RETURNED SAMPLE WAS COMPARED TO A BRAND NEW RETAINED SAMPLE. IT WAS OBSERVED THAT THE ADAPTOR CAP OF THE CHECK VALVE WAS MISSING FROM THE RETURNED SAMPLE. 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. THE CHECK VALVE COMPONENT WAS PROBABLY DETACHED/BROKEN DUE TO HANDLING/WASHING/BRUSHING AFTER MULTIPLE CYCLES OF RE-USE AFTER UNPACKING. ONCE THE COMPONENT OF THE VALVE WAS BROKEN, THE VALVE COULD NO LONGER FUNCTION NORMALLY.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT ALLEGES "LMA CLASSIC WILL NOT DEFLATE." ALLEGED MALFUNCTION REPORTED AS OCCURRING DURING USE. IT WAS REPORTED THERE WAS NO PATIENT INJURY OR CONSEQUENCE.

    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 "LMA CLASSIC WILL NOT DEFLATE." ALLEGED MALFUNCTION REPORTED AS OCCURRING DURING USE. IT WAS REPORTED THERE WAS NO PATIENT INJURY OR CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120179 LMA CLASSIC, REU, SIZE 4 (100040) AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY CAE TELEFLEX MEDICAL SN:8ZQAHKNB

    Patients

    Seq Age Sex Outcome Treatment
    1