BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX

    MDR report key: 13118667 · Received December 30, 2021

    Report

    Report Number
    3012307300-2021-13508
    Event Type
    Malfunction
    Date Received
    December 30, 2021
    Date of Event
    November 12, 2021
    Report Date
    June 9, 2022
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER TEXT: H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. TWO (2) PICTURES WERE ATTACHED, DURING THE ANALYSIS CONDUCTED IT COULD BE OBSERVED A TOP VIEW OF A TRACHEOSTOMY PRODUCT IN ONE PICTURE, WHILE IN THE OTHER IT CAN BE OBSERVED A DAMAGED ON THE TUBE WELDED TO THE FLANGE. VISUAL INSPECTION: THE COMPLAINT SAMPLE WAS VISUALLY INSPECTED AT A DISTANCE OF 12 TO 16 UNDER NORMAL CONDITIONS OF ILLUMINATION ACCORDING PROCEDURE MD01-003 REV. 103. THE TUBE WAS DETECTED BROKEN NEAR TO THE WELDING ARE BETWEEN THE FLANGE AND THE TUBE; THE SIDE WHEN THE DAMAGED WAS DETECTED DOES NO PRESENT ANY MARK THAT WELD OPERATION USUALLY MAKE ON AROUND OF THE EDGE, HOWEVER THE OTHER SIDE DOES. THE FAILURE MODE REPORTED IS CONFIRMED. NO OTHER ANALYSIS WAS PERFORMED. ROOT CAUSE: PER TREND REVIEW FOR THIS FAILURE MODE AN ESCALATION WAS PERFORMED TO INVESTIGATE IT AND DETERMINE THE ROOT CAUSE. ESCALATION WAS INITIATED ON JANUARY 26, 2022 UNDER NCR-001068. CURRENT NCR STATUS - RISK EVALUATION (HRA) AND INVESTIGATION. THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED. ANY RELEVANT DMRS, NCRS, ETS: THERE WERE NO RELEVANT NCR?S, DMR?S OR DA?S FOR THIS LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER STARTED TO USE THE CANNULA ON 2021 FOR REPLACEMENT. HE FOUND A CRACK IN IT ON 2021. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2020824 PORTEX TRACHEOSTOMY TUBE AND TUBE CUFF JOH SMITHS MEDICAL INTERNATIONAL, LTD. 100/506/050 3376307

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown