BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUCTION MCEN766 SINUS TUBE 3MM

    MDR report key: 14664553 · Received June 11, 2022

    Report

    Report Number
    3003249645-2022-00025
    Event Type
    Malfunction
    Date Received
    June 11, 2022
    Date of Event
    May 16, 2022
    Report Date
    July 15, 2022
    Manufacturer
    INTEGRA MICROFRANCE S.A.S.
    Product Code
    JZF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE SINUS SUCTION TUBE (MCEN766) WAS RETURNED FOR EVALUATION: THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES RELATED TO THE REPORTED FAILURE WERE OBSERVED. ROOT CAUSE: EVALUATION OF THE SINUS TUBE SUCTION FOUND THAT THE TUBE WAS UNWELDED AND IT WAS BENT. NO MANUFACTURING DEFECT WAS FOUND; THE LASER WELDING WAS COMPLIANT. FAILURE ANALYSIS: IT WAS DETERMINED THAT THE ISSUE WAS DUE TO AN EXCESSIVE STRENGTH APPLIED ON THE DEVICE OR AN IMPROPER HANDLING DURING THE REPROCESSING OR THE STORAGE. NO FURTHER INVESTIGATION REQUIRED BASED ON THE ACCEPTABILITY OF RISK AND NO ADVERSE TRENDS IDENTIFIED. THIS WILL BE MONITORED AND TRENDED GOING FORWARD.

    Description of Event or Problem · 0

    A FACILITY REPORTED THAT THE CANULA/SINUS SUCTION TUBE (MCEN766) BROKE AT THE TIME OF CONNECTION. THE DEVICE WAS IN CONTACT WITH THE PATIENT. HOWEVER; NO INJURY, DEATH OR SURGICAL DELAY OCCURRED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2144338 SUCTION MCEN766 SINUS TUBE 3MM PFM11 JZF INTEGRA MICROFRANCE S.A.S. 5670475

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown