BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA CUSTOMIZED TRACHEOSTOMY TUBES

    MDR report key: 16950434 · Received May 17, 2023

    Report

    Report Number
    3012307300-2023-05654
    Event Type
    Malfunction
    Date Received
    May 17, 2023
    Date of Event
    April 21, 2023
    Report Date
    September 1, 2023
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K923878
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT AND D4: UDI NUMBER IS UNKNOWN, NO INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. 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

    OTHER TEXT: ADDITIONAL INFORMATION: B3, B5, D4: CATALOG NUMBER, LOT NUMBER (PREVIOUSLY REPORTED AS SERIAL NUMBER), H6 - HEALTH EFFECTS CODES. H3 AND H6 - EVALUATION CODES: UPDATED. DEVICE EVALUATION: TWO DEVICES WERE RECEIVED FOR INVESTIGATION. VISUAL INSPECTION FOUND THE TWO CUSTOM DEVICES RECEIVED WERE A 8.0 HYPERFLEX WITH AN AIRE CUFF AND A 4.0 FLEXTEND WITH A TTS CUFF. ALSO INCLUDED WITH THE DEVICES WAS THE TYVEK TRAY LID WITH A VARIABLE LABEL THAT IDENTIFIED P/N HA19FS80NSZ144 AND LOT GB005514. THE INVESTIGATION DETERMINED THAT THE END USER HAS TWO PART NUMBERS FOR AN 8.0 HYPERFLEX WITH AN AIRE CUFF: ONE WITH A 70MM LENGTH SHAFT (HA19FS80NSZ143 / LOT GB005513) AND ONE WITH A 95MM SHAFT LENGTH (HA19FS80NSZ144 - LOT GB005514). THE COMPLAINT DESCRIPTION INCORRECTLY IDENTIFIED LOT GB005513 FOR THE RETURNED HYPERFLEX DEVICE. THE SHAFT LENGTH OF THE RETURNED HYPERFLEX DEVICE MEASURED 95MM, WHICH MATCHED THE RETURNED TYVEK LID WITH VARIABLE INFORMATION (LOT GB005514). NO LEAKS WERE DETECTED. THE INVESTIGATION DID NOT IDENTIFY A DEFECT WITH THE RETURNED DEVICE. VISUAL INSPECTION OF THE DEVICE IDENTIFIED DISCOLORATION AND STAINING FROM BIOLOGICAL MATTER AND DAMAGE TO THE INFLATION BALLOON AND EYELET. THE AIRWAY BALLOON APPEARED TO HAVE BEEN SEVERELY CHEWED; THE INFLATION VALVE WAS MISSING AS WELL AS A PORTION OF THE SILICONE THAT FORMED THE BALLOON. THE EYELET ON THE RIGHT-SIDE WHEN THE DEVICE IS IN SITU HAD A TEAR AT THE TOP OF THE REINFORCED EYELET THAT WAS COMPLETELY TORN THROUGH. THERE WAS EVIDENCE OF CUTS ON THE OTHER EYELET THAT WITH CONTINUED USE OF A VELCRO TIE WOULD LIKELY PROPAGATE INTO THE CUT THROUGH THE REINFORCED EYELET. THE INVESTIGATION DID NOT IDENTIFY ANY MANUFACTURING DEFECTS WITH THE RETURNED DEVICES. THE CUFFS WERE NOT DAMAGED AND INFLATED/DEFLATED WITHOUT ISSUE. THE DAMAGE IDENTIFIED DURING THE INVESTIGATION FOR THE DEVICE WAS USER INFLICTED. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) FOR ALL REPORTED LOT NUMBERS (GB005596, GB005513 AND GB005514) SHOWED THERE WERE NO OBSERVATIONS OR NONCONFORMITIES RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCTS. NO CORRECTIVE ACTIONS ARE PLANNED AT THIS TIME. ICU MEDICAL REGULARLY ANALYZES COMPLAINT DATA AND TRENDS AND WILL TAKE FURTHER ACTIONS ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BALLOON WAS BROKEN. PATIENT INVOLVEMENT IS UNKNOWN.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THERE WAS NO PATIENT INVOLVEMENT, NO MEDICAL INTERVENTION NO INJURY OR ADVERSE EFFECTS. THE OUTCOME OF THE EVENT WAS RESOLVED. THE EVENT OCCURRED AT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1908032 BIVONA CUSTOMIZED TRACHEOSTOMY TUBES TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. GB005513

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Unknown