BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA PROSEAL, REU, SIZE 3 (150030)

    MDR report key: 8033908 · Received November 2, 2018

    Report

    Report Number
    9681900-2018-00038
    Event Type
    Malfunction
    Date Received
    November 2, 2018
    Date of Event
    October 8, 2018
    Report Date
    October 30, 2018
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    QN#: (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THERE WERE DIRT/STAIN MARKS ON THE CUFF SEAM DUE TO MULTIPLE USES. IT WAS ALSO NOTICED THAT THE AIRWAY TUBE WAS YELLOWISH. UPON CLOSER EXAMINATION OF THE FAILURE LOCATION IT WAS FOUND THERE WERE JAGGED EDGES ON THE CONNECTOR. THE JAGGED EDGES AT WHERE THE CONNECTOR SPLIT APPEARED TO BE RUPTURED BY FORCE. A DEVICE HISTORY RECORD 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 ON THE LMA DEVICE COULD HAVE POSSIBLY ADVERSELY IMPACTED THE STURDINESS OF THE CONNECTOR, WHICH COULD RESULT IN THE CONNECTOR BREAKING WHEN EXTERNAL FORCE IS APPLIED.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT ALLEGES "THE PROSEAL 15MM CONNECTOR BROKE OFF AFTER CONNECTING IT TO THEIR VENTILATOR." NO PATIENT INJURY OR CONSEQUENCE REPORTED. PATIENT CONDITION REPORTED AS FINE.

    Additional Manufacturer Narrative · 1

    QN# (B)(4).

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "THE PROSEAL 15MM CONNECTOR BROKE OFF AFTER CONNECTING IT TO THEIR VENTILATOR". NO PATIENT INJURY OR CONSEQUENCE REPORTED. PATIENT CONDITION REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    873557 LMA PROSEAL, REU, SIZE 3 (150030) AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY CAE TELEFLEX MEDICAL 8WSAL9S4

    Patients

    Seq Age Sex Outcome Treatment
    1 VENTILATOR.| VENTILATOR.