BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUCTION TUBE CP337 125MM ELEVATOR

    MDR report key: 12218275 · Received July 23, 2021

    Report

    Report Number
    2523190-2021-00158
    Event Type
    Malfunction
    Date Received
    July 23, 2021
    Date of Event
    June 30, 2021
    Report Date
    August 10, 2021
    Manufacturer
    INTEGRA MICROFRANCE S.A.S.
    Product Code
    GEG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORD (DHR) - THE DHR WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED FAILURE WAS OBSERVED. THE SUCTION TUBE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION: FAILURE ANALYSIS: THE EVALUATION VERIFIED THE COMPLAINT AS VALID. THE TUBE IS UNWELDED. ACCORDING TO THE CUSTOMER, IT HAS ONLY BEEN STERILIZED ONCE AT RECEIPT. ROOT CAUSE: THIS ISSUE IS DUE TO AN IMPROPER WELDING OF THE TUBE DURING THE MANUFACTURING OPERATIONS. THIS IS A HUMAN ERROR, NOT DETECTED DURING THE FINAL INSPECTION. THERE WAS NO ADVERSE TREND; HOWEVER, A REMINDER HAS BEEN PERFORMED TO THE OPERATORS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A FACILITY REPORTED THAT THE SUCTION TUBE (CP337) RECEIVED A FEW DAYS AGO BROKE AND IT WAS ONLY STERILIZED ONCE. THE CANNULA UNWELDED / UNSOLDERED DURING ITS FIRST HANDLING. THE DEVICE WAS NOT IN CONTACT WITH A PATIENT THUS, THERE WAS NO INJURY, ALLEGED DEATH. THERE WAS NO INCREASED SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118411 SUCTION TUBE CP337 125MM ELEVATOR PFM11 GEG INTEGRA MICROFRANCE S.A.S. 5429778

    Patients

    Seq Age Sex Outcome Treatment
    1