BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX TUBES BLUE LINE ULTRA (BLU)

    MDR report key: 15725041 · Received November 4, 2022

    Report

    Report Number
    3012307300-2022-26700
    Event Type
    Malfunction
    Date Received
    November 4, 2022
    Report Date
    November 17, 2022
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    BTO
    PMA / PMN Number
    K173384
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. NO PRODUCT WAS RETURNED FOR INVESTIGATION. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION WAS COMPLETED. NO PRODUCT WAS RETURNED FOR INVESTIGATION. THREE (3) PICTURES WERE ATTACHED AND REVIEWED. PICTURE ONE SHOWS A TABLE OF CANNULA DIMENSIONS RANGES FOR MULTIPLES CANNULA SIZES. PICTURE TWO IS NOT CLEAR. PICTURE THREE SHOWS THE CUFF LINE CONNECTED TO A SYRINGE AND BUBBLES ARE VISIBLE. PER THE ATTACHED IMAGE LEAKAGE COMPLAINT IS CONFIRMED. FUNCTIONAL TESTING: NO PRODUCT WAS RETURNED FOR ANALYSIS. WE ARE UNABLE TO CONFIRM THE REPORTED COMPLAINT. THE ROOT CAUSE CANNOT BE DETERMINED SINCE NO DEVICE WAS RETUNED FOR ANALYSIS. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. A DHR (DEVICE HISTORY REVIEW) WAS PERFORMED AND NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DHR REVIEW. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 IF ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE MEXICO GOVERNMENT SALES AREA RECEIVED A NON-COMPLIANCE REPORT DATED ON (B)(6) 2022, REGARDING A PVC, PORTEX, BLUE LINE ULTRA DISPOSABLE TRACHEOSTOMY CANNULA, WITH CATALOG NO. 100/810/080 AND LOT: 4059501, SANITARY REGISTRY: (B)(4) SSA. THE IMSS BIDDING EVENT INVOLVES 41 PIECES OF THE AFOREMENTIONED DEVICE. 8 PIECES WERE ANALYZED BY THE LABORATORY OF NON-METALLIC MATERIALS OF THE DIVISION OF HEALING MATERIALS AND INSTRUMENTS OF THE IMSS (INSTITUTO MEXICANO DEL SEGURO SOCIAL), WHICH FOUND THAT THE SAMPLES OF THE PRODUCT DID NOT COMPLY WITH THE QUALITY SPECIFICATIONS OF THE CNIS (NATIONAL COMPENDIUM OF HEALTH SUPPLIES) AND THE FEUM-SDM-2017-4ED.; FINDING DISCREPANCIES IN THE INTERNAL AND EXTERNAL DIAMETERS OF THE CANNULA (WITH VALUES HIGHER THAN THOSE SPECIFIED IN THE REFERENCE MONOGRAPH) THE ENDOCANULA INTERNAL DIAMETER SPECIFICATION WAS 8,0 +/- 2 MM, AND WAS FOUND TO HAVE 8,3 MM. THE EXTERNAL DIAMETER SPECIFICATION WAS 11,3 +/- 0,5 MM, AND WAS FOUND TO HAVE 12,1 MM. THE SAMPLES ALSO PRESENTED LEAKAGE IN THE BALLOON OF THE CANNULA AND ITS PILOT BALLOON. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2022: OF THE 8 PIECES CHOSEN, NONE OF THEM MEETS THE MEASUREMENT STANDARDS IN TERMS OF INTERNAL AND EXTERNAL DIAMETER OF THE INPUT, ESTABLISHED IN THE SUPPLEMENT FOR MEDICAL DEVICES, FOURTH EDITION OF THE PHARMACOPOEIA OF THE UNITED MEXICAN STATES, MEXICO 2017. THE TESTS ARE CARRIED OUT ON THE BALLOONS, FOUND LEAKS IN THE BALLOON IN 3 PIECES AND IN THE PILOT BALLOON IN 2 PIECES. WITH THESE RESULTS, THE REST OF THE TESTS ESTABLISHED IN THE FEUM FOR THE INPUT WERE SUSPENDED AND THE ENTIRE BATCH WAS DECLARED AS NOT COMPLIANT. A PICTURE OF A TABLE WITH THE TESTS RESULTS WAS ATTACHED TO THE COMPLAINT OBJECT. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496449 PORTEX TUBES BLUE LINE ULTRA (BLU) TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL INTERNATIONAL, LTD. 4059501

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown