BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA PROSEAL, REU, SIZE 4 (150040)

    MDR report key: 6357284 · Received February 24, 2017

    Report

    Report Number
    9681900-2017-00014
    Event Type
    Malfunction
    Date Received
    February 24, 2017
    Date of Event
    January 3, 2017
    Report Date
    February 7, 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 INVESTIGATION INTO THIS COMPLAINT IS STILL IN PROGRESS AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THE AIRWAY TUBE WAS DISCOLORED. IT WAS ALSO NOTICED THERE WERE JAGGED EDGES ON THE BROKEN CONNECTOR. THE JAGGED EDGES APPEARED TO BE RUPTURED BY FORCE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. THE CONCENTRATION OF DETERGENT AND HOLDING TIME OF THE AUTOCLAVING SETTING WERE UNKNOWN. A CONCENTRATED DETERGENT OR OVERRUN HOLDING TIME COULD HAVE POSSIBLY ADVERSELY IMPACTED THE STURDINESS OF THE CONNECTOR PROPERTIES, WHICH THEREFORE COULD HAVE BEEN ADVERSELY IMPACTED WHEN EXTERNAL FORCE WAS APPLIED.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THE CONNECTOR SHEARED OFF WHEN DISCONNECTED FROM THE CATHETER MOUNT DURING TRANSFER FROM THE OPERATING ROOM. ALLEGED MALFUNCTION OCCURRED DURING USE. AIRWAY WAS REPLACED. NO INJURY TO PATIENT REPORTED.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THE CONNECTOR SHEARED OFF WHEN DISCONNECTED FROM THE CATHETER MOUNT DURING TRANSFER FROM THE OPERATING ROOM. ALLEGED MALFUNCTION OCCURRED DURING USE. AIRWAY WAS REPLACED. NO INJURY TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139593 LMA PROSEAL, REU, SIZE 4 (150040) AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY CAE TELEFLEX MEDICAL 8VRAV6VJ

    Patients

    Seq Age Sex Outcome Treatment
    1 CATHETER MOUNT