BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUCTION TUBE MCO770-3-0 120MM DIA 3.0MM

    MDR report key: 14166707 · Received April 21, 2022

    Report

    Report Number
    3003249645-2022-00015
    Event Type
    Malfunction
    Date Received
    April 21, 2022
    Date of Event
    February 14, 2022
    Report Date
    July 12, 2022
    Manufacturer
    INTEGRA MICROFRANCE S.A.S.
    Product Code
    JZF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 SUCTION TUBE (MCO770) 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 DEVICE FOUND THAT THE SUCTION WAS BROKEN AT THE WELDING. THE WELDING WAS COMPLIANT, AND NO MANUFACTURING DEFECT WAS FOUND. THE THICKNESS OF THIS TUBE IS VERY THIN, SO IT IS FRAGILE. FAILURE ANALYSIS: AS NO MANUFACTURING DEFECT WAS FOUND, THIS ISSUE IS PROBABLY DUE TO A BAD HANDLING OF THE DEVICE DURING THE STORAGE OR THE REPROCESSING. 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 A BREAKAGE BETWEEN CANNULA AND HANDLE OF A SUCTION TUBE (ID MCEN115-9). NO ASPIRATION WAS POSSIBLE DURING SURGERY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2327789 SUCTION TUBE MCO770-3-0 120MM DIA 3.0MM PFM11 JZF INTEGRA MICROFRANCE S.A.S. 5900636

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown