BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA FLEXTEND TTS PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBE

    MDR report key: 10012629 · Received April 30, 2020

    Report

    Report Number
    3012307300-2020-03346
    Event Type
    Malfunction
    Date Received
    April 30, 2020
    Date of Event
    March 31, 2020
    Report Date
    July 10, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    10351688518606
    PMA / PMN Number
    K923878
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION COMPLETED ON A SMITH MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES NEO/PED. DEVICE RECEIVED WITH L/N 3832010. THE DEVICE WAS VISUALLY INSPECTED WITH NO DAMAGE NOTED. TESTING DONE ACCORDING TO THE IFU (10018859-001 REV.100 - INSTRUCTION FOR USE - BIVONA TTS FLEXTEND TRACHEOSTOMY) THE CUFF WAS MANIPULATED AND THE WHOLE CUFF INFLATED. AFTER THE WHOLE CUFF INFLATED, IT WAS DEFLATED AND INFLATED 4 TIMES, ALL THE TIMES THE CUFF INFLATED COMPLETELY. PICTURES PROVIDED. AS PREVENTIVE ACTION PRODUCTION PERSONNEL WAS NOTIFIED BY QUALITY ENGINEER ON (B)(6) 2020 AS AWARENESS OF THE DEFECT REPORTED BY THE CUSTOMER. THE COMPLAINT COULD NOT BE VERIFIED OR VALIDATED. NO FAULT FOUND WITH DEVICE.

    Description of Event or Problem · 0

    INVESTIGATION COMPLETED ON A SMITHS MEDICAL INVESTIGATION COMPLETED ON A SMITH MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES NEO/PED. SUMMARY IN H-10.

    Additional Manufacturer Narrative · 1

    FOREIGN REPORT SOURCE: (B)(6).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT THE CUFF WAS NOT INFLATING ON A SMITHS MEDICAL BIVONA FLEXTEND TTS PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBE. A TRACH CHANGE WAS DONE TO RESOLVE THE ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477122 BIVONA FLEXTEND TTS PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF PRODUCT CODE: JOH JOH SMITHS MEDICAL ASD, INC. 67PFS30 3832010 10351688518606

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Required Intervention