BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA PROSEAL, REU, SIZE 4 (150040)

    MDR report key: 7985731 · Received October 19, 2018

    Report

    Report Number
    9681900-2018-00035
    Event Type
    Malfunction
    Date Received
    October 19, 2018
    Date of Event
    October 2, 2018
    Report Date
    October 2, 2018
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    QN#: (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THERE WAS A HOLE IN THE CUFF. IT WAS ALSO NOTICED THAT THE CUFF SHOWED SIGNS OF LOSING ITS RESILIENCE DUE TO STRESS AT THE FAILURE LOCATION. THE GLUE LINE AT THE JOINT OF THE CUFF WAS INTACT. THE CHECK VALVE WAS TESTED AND FOUND TO BE FUNCTIONING AS INTENDED. NO BLOCKAGE WAS 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. IT IS SUSPECTED THAT THERE WAS SOME KIND OF RESIDUAL AIR/MOISTURE THAT WAS LEFT INSIDE THE DEVICE WHILE RE-PROCESSING/HANDLING THAT CAUSED THE CUFF TO RUPTURE. DURING HIGH TEMPERATURE, VACUUM, AND HUMID AUTOCLAVING ENVIRONMENT, ANY AIR/MOISTURE LEFT INSIDE THE CUFF WILL EXPAND SIGNIFICANTLY AND IT WILL DAMAGE THE PROPERTIES OF THE DEVICE TO AN IRREPARABLE CONDITION.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT ALLEGES "BACK SIDE OF LMA RUPTURED. ANETHESIOLOGIST NOTICED WHEN TAKING OUT OF STERILE PACK TO PREP FOR A CASE." ALLEGED ISSUE REPORTED AS DETECTED PRIOR TO USE ON PATIENT. IT WAS REPORTED THERE WAS NO PATIENT HARM.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "BACK SIDE OF LMA RUPTURED. ANESTHESIOLOGIST NOTICED WHEN TAKING OUT OF STERILE PACK TO PREP FOR A CASE." ALLEGED ISSUE REPORTED AS DETECTED PRIOR TO USE ON PATIENT. IT WAS REPORTED THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826150 LMA PROSEAL, REU, SIZE 4 (150040) AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY CAE TELEFLEX MEDICAL SN:8VTAG5BE

    Patients

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