BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA PROSEAL, REU, SIZE 4 (150040)

    MDR report key: 7341465 · Received March 15, 2018

    Report

    Report Number
    9681900-2018-00020
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    February 18, 2018
    Report Date
    February 26, 2018
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    PMA / PMN Number
    K780900
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THE RECORD CARD THAT WAS RETURNED WITH THE DEVICE WAS STAINED WITH GLUE. THE DEVICE WAS INSPECTED AND IT WAS FOUND THAT THE CHECK VALVE OF THE DEVICE WOULD FUNCTION NORMALLY, AND THAT THE SYRINGE COULD BLOW AIR INTO AND WITHDRAW AIR FROM THE DEVICE. IT WAS ALSO OBSERVED THAT THE DEVICE COULD NOT HOLD DEFLATION. WHEN THE DEVICE WAS IMMERSED IN WATER AN AIR LEAK WAS FOUND ON THE CUFF OF THE DEVICE. THERE WAS NO CHANGE IN THE MANUFACTURING PROCESS. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE SERIAL NUMBER OF THE RETURNED DEVICE (8VRAZW6Y) AND THERE WERE NO ABNORMALITIES FOUND. BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT WAS CONFIRMED. THE ROOT CAUSE IS MANUFACTURER RELATED. RELEVANT PARTIES WERE MADE AWARE OF THE INCIDENT AND WERE ARTICULATED OF ALL STEPS (OPERATION AND INSPECTION) TO BE FOLLOWED AS SPECIFIED IN THE WORK INSTRUCTION.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT ALLEGES THAT THE DEVICE WILL NOT DEFLATE. ALLEGED ISSUE DETECTED DURING FUNCTIONAL TESTING PRIOR TO USE ON A PATIENT. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

    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 THAT THE DEVICE WILL NOT DEFLATE. ALLEGED ISSUE DETECTED DURING FUNCTIONAL TESTING PRIOR TO USE ON A PATIENT. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183617 LMA PROSEAL, REU, SIZE 4 (150040) AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY CAE TELEFLEX MEDICAL SN:8VRAZY6Y

    Patients

    Seq Age Sex Outcome Treatment
    1