BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX UNIPERC INNER CANNULAE

    MDR report key: 9833561 · Received March 16, 2020

    Report

    Report Number
    3012307300-2020-02018
    Event Type
    Malfunction
    Date Received
    March 16, 2020
    Date of Event
    February 14, 2020
    Report Date
    July 11, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BTO
    UDI-DI
    15019315107221
    PMA / PMN Number
    K083031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS COMPLETED ON A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES PDT UNIPERC . DEVICE RECEIVED 7MM IN PLASTIC BAG WITH PHOTOS PROVIDED.. WHEN INSPECTING DEVCIE IT WAS CONFIRMED THE BLUE LOCKING LEVER IS INCORRECTILY SCREWEED WITH FLANGE BODY WHICH WAS CAUSING THE ISSUE. WE UNSCREWED LOCKING LEVER FROM FLANGE BODY AND ASSEMBLED IT BACK CORRECTLY. WE CAN CONFIRM THAT AFTER CORRECT ASSEMBLY LOCKING MECHANISM WORKS WELL (SEE ATTACHED PHOTO OF SAMPLE AFTER REPAIR). SIMILAR CUSTOMER COMPLAINTS WHERE THE SAME ISSUES RELATED TO UNIPERC FLANGE LOCKING MECHANISM WERE RAISED IN PAST AND THEREFORE PATTERN OBJECT PTN-00039 WAS CREATED.THIS ISSUE WAS ESCALATED TO COMPLAINT TREND PROCESS AS PER DVSOP5007 AND IS TRACKED UNER REVIEW-101279. NO FINDING IN THE DHR WHEN REVIEWING MANUFACTURING.

    Additional Manufacturer Narrative · 0

    B5 AND H6 WERE UPDATED TO REFLECT NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    INVESTIGATION COMPLETED ON ON A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES PDT UNIPERC.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED THAT THE BLUE LOCK SYSTEM ON A SMITHS MEDICAL REGARDING A PORTEX UNIPERC INNER CANNULA DID NOT WORK. NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    FOREIGN REPORT SOURCE: (B)(6).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT THE BLUE LOCKSYSTEM ON A SMITHS MEDICAL REGARDING A PORTEX UNIPERC INNER CANNULA DID NOT WORK. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298429 PORTEX UNIPERC INNER CANNULAE TUBE, TRACHEOSTOMY (W/WO CONNECTOR) PRODUCT CODE: BTO BTO SMITHS MEDICAL ASD, INC. 100/899/070CZ 3827426 15019315107221

    Patients

    Seq Age Sex Outcome Treatment
    1