BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA PROSEAL, REU, SIZE 4 (150040)

    MDR report key: 6332668 · Received February 15, 2017

    Report

    Report Number
    9681900-2017-00013
    Event Type
    Malfunction
    Date Received
    February 15, 2017
    Date of Event
    January 23, 2017
    Report Date
    January 24, 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). 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 THERE WAS DIRT AND STAINS ON THE DEVICE. IT WAS ALSO NOTICED THAT THERE WERE SOME JAGGED EDGES ON BOTH SIDES OF THE BROKEN CONNECTOR. THE JAGGED EDGES AT WHERE THE CONNECTOR SPLIT APPEARED TO BE RUPTURED BY FORCE. THE CONCENTRATION OF DETERGENT AND HOLDING TIME OF THE AUTOCLAVING SETTING WERE NOT KNOWN. IT IS POSSIBLE THAT ONE OF THESE FACTORS COULD HAVE ADVERSELY IMPACTED THE STURDINESS OF THE CONNECTOR. PER THE INSTRUCTIONS FOR USE (IFU), THE LMA PROSEAL SHOULD BE PROCESSED WITH A MILD DETERGENT SUCH AS AN ENZYMATIC CLEANING AGENT, WITH AUTOCLAVING TIME (TIME HELD) OF 10 MINUTES AT 134 DEGREES C. THE CONNECTOR MUST BE INSPECTED FOR CRAZING PRIOR TO USE. THE ROOT CAUSE OF THE ISSUE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    QN#(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 IT IN PROGRESS.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THAT THE "TOP CONNECTOR SHEARED OFF WHEN CONNECTING TO CATHETER MOUNT." ALLEGED DEFECT DETECTED DURING USE (INDUCTION). A NEW DEVICE WAS USED. NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THAT THE "TOP CONNECTOR SHEARED OFF WHEN CONNECTING TO CATHETER MOUNT." ALLEGED DEFECT DETECTED DURING USE (INDUCTION). A NEW DEVICE WAS USED. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117285 LMA PROSEAL, REU, SIZE 4 (150040) AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY CAE TELEFLEX MEDICAL 8VRAQJVH

    Patients

    Seq Age Sex Outcome Treatment
    1 CATHETER MOUNT