BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA

    MDR report key: 12238199 · Received July 28, 2021

    Report

    Report Number
    3012307300-2021-07707
    Event Type
    Malfunction
    Date Received
    July 28, 2021
    Report Date
    August 19, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K923878
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: VISUAL INSPECTION OF THE RETURNED DEVICE SHOWED THAT THE PROXIMAL CUFF WAS TORN (REFERENCE PICTURES). THE DEVICE WAS COMPARED TO THE TEMPLATE AND THE MANUFACTURING DRAWING, ZT21CN80ZSZ082, AND WAS DETERMINED TO BE MANUFACTURED TO THE SPECIFICATIONS PROVIDED BY THE CUSTOMER. CUSTOM DEVICES ARE 200 PERCENT. INSPECTED AND FUNCTION TESTED. PER THE DHR, THE DEVICE PASSED ALL INSPECTIONS. THE INSTRUCTION FOR USE, IM-GAR-10018908-001, STATES UNDER WARNINGS TO GUARD AGAINST PRODUCT DAMAGE BY AVOIDING CONTACT WITH SHARP EDGES, AND UNDER CAUTIONS THAT DURING REPROCESSING, AGGRESSIVE SCRUBBING OF THE TUBE OR USE OF HARD BRISTLED BRUSHES OR SHARP WIRE MOUNTED SWABS MAY DAMAGE THE SURFACE OF THE TUBE. THE INVESTIGATION DID NOT DETERMINE A MANUFACTURING DEFECT WITH THE DEVICE. NO. CORRECTIVE ACTIONS ARE PLANNED AT THIS TIME. SMITHS MEDICAL REGULARLY ANALYZES COMPLAINT DATA AND TRENDS AND WILL TAKE FURTHER ACTIONS ACCORDINGLY.

    Description of Event or Problem · 0

    DEVICE EVALUATION COMPLETED AND SUMMARY IN H 10.

    Additional Manufacturer Narrative · 1

    RETURNED DEVICE WAS RECEIVED IN WORN PHYSICAL CONDITION. DURING THE EVALUATION OF THE DEVICE, THE PROXIMAL CUFF WAS FOUND TO BE TORN. CUSTOM DEVICES ARE 200% INSPECTED AND FUNCTION TESTED. PER THE DHR, THE DEVICE PASSED ALL INSPECTIONS. THE INSTRUCTION FOR USE, IM-GAR-10018908-001, STATES UNDER WARNINGS TO GUARD AGAINST PRODUCT DAMAGE BY AVOIDING CONTACT WITH SHARP EDGES, AND UNDER CAUTIONS THAT DURING REPROCESSING, AGGRESSIVE SCRUBBING OF THE TUBE OR USE OF HARD BRISTLED BRUSHES OR SHARP WIRE MOUNTED SWABS MAY DAMAGE THE SURFACE OF THE TUBE. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. PHONE: (B)(6).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL TRACHEOSTOMY TUBE WAS IMPLICATED IN AN UNKNOWN INJURY. THERE WERE NO REPORTED ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1136543 BIVONA TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. ZT21CN80ZSZ082N

    Patients

    Seq Age Sex Outcome Treatment
    1