BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA CLASSIC, REU, SIZE 4 (100040)

    MDR report key: 8124905 · Received December 3, 2018

    Report

    Report Number
    9681900-2018-00041
    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

    (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 BRAND NEW RETAINED SAMPLE WAS COMPARED TO THE RETURNED SYRINGE. ON THE RETURNED SAMPLE, IT WAS OBSERVED THAT THE ADAPTOR CAP OF THE CHECK VALVE WAS MISSING. WHEN THE DEVICE WAS CONNECTED TO A SYRINGE, THE SYRINGE WAS UNABLE TO BLOW AIR INTO THE DEVICE OR EXTRACT AIR FROM IT. THE REPORTED FAILURE WAS VERIFIED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. THE BRAND NEW RETAINED SAMPLE WAS THEN SENT FOR SIMULATING THE PROCESS OF CONNECTING WITH A SYRINGE AND DISCONNECTING FROM IT MORE THAN 10 CYCLES. THE ADAPTOR CAP ON THE CHECK VALVE DID NOT DETACH DURING THE SIMULATION. IT WAS DETERMINED THAT THE CHECK VALVE COMPONENT WAS MOST LIKELY DETACHED/BROKEN DUE TO HANDLING/WASHING/BRUSHING AFTER MULTIPLE CYCLES OF RE-USE AFTER UNPACKING. WHILE PREPARING/WASHING/BRUSHING THE REUSABLE DEVICE WITH TOOLS, THEY SHOULD NOT COME IN CONTACT WITH THE CHECK VALVE. ONCE THE COMPONENT OF THE VALVE IS BROKEN/DETACHED, THE VALVE CAN NO LONGER FUNCTION NORMALLY.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT ALLEGES "AIR DOES NOT ENTER THE MASK AFTER THE 10TH USE". ALLEGED DEFECT REPORTED DETECTED PRIOR TO INSERTION. ANOTHER DEVICE WAS OBTAINED FOR USE. NO PATIENT HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT ALLEGES "AIR DOES NOT ENTER THE MASK AFTER THE 10TH USE". ALLEGED DEFECT REPORTED DETECTED PRIOR TO INSERTION. ANOTHER DEVICE WAS OBTAINED FOR USE. NO PATIENT HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "AIR DOES NOT ENTER THE MASK AFTER THE 10TH USE". ALLEGED DEFECT REPORTED DETECTED PRIOR TO INSERTION. ANOTHER DEVICE WAS OBTAINED FOR USE. NO PATIENT HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966354 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.| NONE REPORTED.