BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA PROSEAL, REU, SIZE 4 (150040)

    MDR report key: 6629525 · Received June 9, 2017

    Report

    Report Number
    9681900-2017-00029
    Event Type
    Malfunction
    Date Received
    June 9, 2017
    Date of Event
    May 15, 2017
    Report Date
    June 8, 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 STILL IN PROGRESS.

    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 AND THE CONNECTOR WAS BROKEN. UPON CLOSER EXAMINATION IT WAS DISCOVERED THAT THERE WERE JAGGED EDGES ON THE BROKEN CONNECTOR. THE JAGGED EDGES WHERE THE CONNECTOR SPLIT 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 IN THE AUTOCLAVE COULD HAVE ADVERSELY IMPACTED THE STURDINESS OF THE CONNECTOR. PER THE IFU RECOMMENDATION, PROCESS THE LMA PROSEAL WITH A MILD DETERGENT SUCH AS ENZYMATIC CLEANING AGENTS WITH AUTOCLAVING TIME (HOLD TIME) OF 10 MINUTES AT 134 DEGREES C.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THAT THE DEVICE "WAS FOUND TO BE INCOMPLETE WHEN IN THE PATIENT'S AIRWAY ". IT WAS REPORTED THERE WAS NO PATIENT INJURY. IT WAS REPORTED THERE WAS MEDICAL INTERVENTION. MEDICAL INTERVENTION DETAIL WAS NOT PROVIDED.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THAT THE DEVICE "WAS FOUND TO BE INCOMPLETE WHEN IN THE PATIENT'S AIRWAY ". IT WAS REPORTED THERE WAS NO PATIENT INJURY. IT WAS REPORTED THERE WAS MEDICAL INTERVENTION. MEDICAL INTERVENTION DETAIL WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413391 LMA PROSEAL, REU, SIZE 4 (150040) AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY CAE TELEFLEX MEDICAL SN:8VRAVR3K

    Patients

    Seq Age Sex Outcome Treatment
    1