BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUCTION TUBE MCLT50 MALLEAB BLUNT TERRIS

    MDR report key: 8744938 · Received June 28, 2019

    Report

    Report Number
    2523190-2019-00087
    Event Type
    Malfunction
    Date Received
    June 28, 2019
    Date of Event
    June 18, 2019
    Report Date
    June 18, 2019
    Manufacturer
    INTEGRA MICROFRANCE S.A.S.
    Product Code
    KAC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RETURNED FOR EVALUATION. THERE WAS ONE MALLEABLE BLUNT SUCTION TUBE RETURNED USED/PROCESSED SHOWING WEAR WITH THE COMPLAINT THAT THERE IS TISSUE IN THE TUBE. LOT NUMBER WAS NOT RECEIVED TO PERFORM DEVICE HISTORY RECORD REVIEW. INSTRUMENT WAS CHECKED UNDER THE MICROSCOPE AND COULD NOT DETECT ANYTHING IN THE TUBE. IN ADDITION, WATER FLOW TESTING WAS COMPLETED BY HAVING THE WATER RUN THROUGH THE TOP OF THE INSTRUMENT AND IT DRAINED DOWN THE TWO HOLES AT THE BOTTOM FREELY. THIS COMPLAINT IS UNCONFIRMED. COULD NOT DUPLICATE REPORTED INCIDENT. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED.

    Description of Event or Problem · 1

    A SALES SPECIALIST REPORTED ON BEHALF OF THE CUSTOMER THAT ON (B)(6) 2019, AN MCLT50 SUCTION TUBE MALLEAB BLUNT TERRIS WAS CONTAMINATED WITH TISSUE DEBRIS. THE REPORTED ISSUE WAS DISCOVERED PRIOR TO USE. THE PATIENT WAS BEING PREPPED IN THE OR (OPERATING ROOM) FOR A THYROIDECTOMY (INCISION) PROCEDURE. THERE WAS NO PATIENT CONTACT, AND NO PATIENT INJURY REPORTED. THE ACTION THAT WAS TAKEN AFTER THE PRODUCT PROBLEM OCCURRED WAS THAT THE PRODUCT WAS REMOVED FROM THE STERILE FIELD, DECONTAMINATED, AND FLASH STERILIZED. A 20-MINUTE SURGICAL DELAY WITH NO ADVERSE CONSEQUENCES WAS REPORTED. NO REVISION/MEDICAL INTERVENTION WAS REQUIRED. PRODUCT WAS THEN USED IN THE THYROIDECTOMY CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536389 SUCTION TUBE MCLT50 MALLEAB BLUNT TERRIS PFM11 KAC INTEGRA MICROFRANCE S.A.S.

    Patients

    Seq Age Sex Outcome Treatment
    1