BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA PROSEAL, REU, SIZE 4 (150040)

    MDR report key: 6598307 · Received May 30, 2017

    Report

    Report Number
    9681900-2017-00025
    Event Type
    Malfunction
    Date Received
    May 30, 2017
    Date of Event
    January 5, 2017
    Report Date
    May 12, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVOLVED IN THIS COMPLAINT HAS NOT BEEN RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. THE INVESTIGATION INTO THIS COMPLAINT IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THE DEVICE WAS DISCOLORED. IT WAS ALSO NOTICED THAT THERE WERE SOME JAGGED EDGES (SYMPTOMS OF CRACKS DUE TO FORCE) ON THE BROKEN CONNECTOR. THE JAGGED EDGES WHERE THE CONNECTOR SPLIT APPEARED TO BE RUPTURED BY FORCE. BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT WAS CONFIRMED. THE TYPE OF DETERGENT USED, CONCENTRATION OF DETERGENT, AND AUTOCLAVING SETTINGS WERE UNKNOWN. A NON-COMPATIBLE DETERGENT OR CONCENTRATED DETERGENT, OR HIGH AUTOCLAVE TEMPERATURE, COULD HAVE ADVERSELY IMPACTED THE STURDINESS OF THE CONNECTOR WHEN EXTERNAL FORCES WERE APPLIED. IN ADDITION, IF THE LMA PROSEAL IS STERILIZED TOGETHER WITH LUBRICATED MEDICAL INSTRUMENTS, THE LUBRICANT WILL ACCELERATE DETERIORATION OF THE CONNECTOR.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "PRIOR TO USE NOTICED CONNECTOR ABSENT. SHEARED OFF." USAGE OF THE DEVICE AT THE TIME OF THE REPORTED EVENT IS UNCLEAR. THERE WAS NO REPORT OF PATIENT HARM.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "PRIOR TO USE NOTICED CONNECTOR ABSENT. SHEARED OFF." USAGE OF THE DEVICE AT THE TIME OF THE REPORTED EVENT IS UNCLEAR. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380186 LMA PROSEAL, REU, SIZE 4 (150040) AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY CAE TELEFLEX MEDICAL 8VRAT9PY

    Patients

    Seq Age Sex Outcome Treatment
    1