BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA PROSEAL, REU, SIZE 4 (150040)

    MDR report key: 7130746 · Received December 19, 2017

    Report

    Report Number
    9681900-2017-00048
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    December 1, 2017
    Report Date
    December 5, 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 SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THE SAMPLE WAS DISCOLORED. UPON CLOSER OBSERVATION AT THE FAILURE LOCATION, IT WAS OBSERVED THERE WERE SOME JAGGED EDGES (SYMPTOMS OF CRACKS DUE TO FORCE) ON THE BROKEN CONNECTOR. THE JAGGED EDGES AT WHERE THE CONNECTOR SPLIT APPEARED TO BE RUPTURED BY FORCE. THE DHR WAS REVIEWED AND THERE WERE NO ISSUES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. THE CONCENTRATION OF DETERGENT AND HOLDING TIME OF THE AUTOCLAVING SETTINGS WERE UNKNOWN. A CONCENTRATED DETERGENT OR OVERRUN HOLDING TIME COULD HAVE POSSIBLY ADVERSELY IMPACTED THE STURDINESS OF THE CONNECTOR WHEN EXTERNAL FORCE WAS APPLIED. A CONCLUSION CODE COULD NOT BE FOUND AS THE COMPLAINT WAS CONFIRMED; HOWEVER, A ROOT CAUSE COULD NOT BE ESTABLISHED.

    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 "THE END OF THE TUBE HAS SNAPPED OFF WHILST IN THE PATIENTS AIRWAY." REQUIRED MEDICAL INTERVENTION WAS TO REPLACE THE LMA. PATIENT CONDITION WAS REPORTED AS "FINE".

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "THE END OF THE TUBE HAS SNAPPED OFF WHILST IN THE PATIENTS AIRWAY." REQUIRED MEDICAL INTERVENTION WAS TO REPLACE THE LMA. PATIENT CONDITION WAS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908216 LMA PROSEAL, REU, SIZE 4 (150040) AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY CAE TELEFLEX MEDICAL 8VRA2Q56

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention