BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA PROSEAL, REU, SIZE 4 (150040)

    MDR report key: 8174892 · Received December 18, 2018

    Report

    Report Number
    9681900-2018-00044
    Event Type
    Malfunction
    Date Received
    December 18, 2018
    Date of Event
    December 4, 2018
    Report Date
    December 4, 2018
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THE CONNECTOR ON THE DEVICE WAS BROKEN. IT WAS ALSO FOUND THAT THERE WERE CRAZED LINES ON THE CONNECTOR. THE CRAZED LINES ON THE SURFACE OF THE CONNECTOR WERE SMOOTH TO THE TOUCH. UPON CLOSER OBSERVATION IT WAS NOTICED THAT 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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. BASED ON THE INVESTIGATION PERFORMED THE REPORTED COMPLAINT WAS CONFIRMED. THE USE OF NON-COMPATIBLE DETERGENT OR CONCENTRATED DETERGENT, OR ADD-ON WASHING AGENTS SUCH AS LUBRICANT ON THE DEVICE COULD HAVE POSSIBLE ADVERSELY IMPACTED THE STURDINESS OF THE CONNECTOR PROPERTIES WHICH COULD RESULT IN THE CONNECTOR BREAKING WHEN EXTERNAL FORCE IS APPLIED. PER THE IFU RECOMMENDATION, TO PROCESS THE LMA PROSEAL WITH A MILD DETERGENT SUCH AS ENZYMATIC CLEANING AGENTS WITH AUTOCLAVING TIME (HELD TIME) OF 10 MINUTES AT 134DEGREES C. DISINFECTANTS IS NOT RECOMMENDED AS PER IFU.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT ALLEGES "AFTER INSERTING THE LMA INTO THE PATIENT, UPON CONNECTING THE PROSEAL TO THE BREATHING CIRCUIT, THE 15MM CONNECTOR BROKE OFF". NO PATIENT HARM REPORTED. PATIENT CONDITION REPORTED AS FINE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "AFTER INSERTING THE LMA INTO THE PATIENT, UPON CONNECTING THE PROSEAL TO THE BREATHING CIRCUIT, THE 15MM CONNECTOR BROKE OFF". NO PATIENT HARM REPORTED. PATIENT CONDITION REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015379 LMA PROSEAL, REU, SIZE 4 (150040) AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY CAE TELEFLEX MEDICAL 8VRAKAU5

    Patients

    Seq Age Sex Outcome Treatment
    1 BREATHING CIRCUIT.| BREATHING CIRCUIT.