BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUCTION TUBE MCEN78J30 DIA3MM JANKOWSKI

    MDR report key: 14031254 · Received April 6, 2022

    Report

    Report Number
    3003249645-2022-00010
    Event Type
    Malfunction
    Date Received
    April 6, 2022
    Date of Event
    March 16, 2022
    Report Date
    May 16, 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 JANKOWSKI SUCTION TUBE (MCEN78J30) WAS RETURNED FOR EVALUATION: THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES RELATED TO THE REPORTED FAILURE WERE OBSERVED. FAILURE ANALYSIS: EVALUATION OF THE SUCTION TUBE VERIFIED THE COMPLAINT REPORTED BY THE CUSTOMER AS VALID. THE DEVICE WAS BROKEN NEAR THE LASER WELDING. THE TUBE WAS BENT NEAR THE BREAKAGE AREA. NO MANUFACTURING DEFECT WAS FOUND. ROOT CAUSE ANALYSIS: IT WAS DETERMINED THAT THIS ISSUE WAS LIKELY DUE TO AN EXCESSIVE EFFORT APPLIED ON THE DEVICE DURING THE USE, THE REPROCESSING OR THE STORAGE OF THE DEVICE.

    Description of Event or Problem · 0

    THIS REPORT IS 2 OF 2 LINKED TO MFG REPORT NUMBER 3003249645-2022-00011: A FACILITY REPORTED THAT DURING A SINUS INTERVENTION PROCEDURE, AFTER THE SUCTION TUBE (MCEN78J30) WAS INTRODUCED INTO PATIENT'S NOSE, THE CANNULA BROKE WHEN SUCTION WAS INITIATED. THE ISSUE OCCURRED TWICE DURING THE SURGERY, AND A 3RD CANNULA WAS USED. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE CANNULA BROKE AT CURVATURE (BENT) IN THE PATIENT'S NOSE, BUT NO LESION/INJURY FOR THE PATIENT. THE BROKEN PARTS CAME OUT OF THE NOSE WITHOUT ANY INTERVENTION BY THEMSELVES. THE EVENT DID NOT LEAD TO INCREASED SURGERY TIME.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400964 SUCTION TUBE MCEN78J30 DIA3MM JANKOWSKI PFM11 JZF INTEGRA MICROFRANCE S.A.S. 5561443

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown