MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA CUSTOM TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	FT15AN35NSA151N
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation 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.Device expiration date and device manufacturing date not available.
Event or Problem Description
It was reported the device whistles.No patient injury was reported.Additional information received via customer response email on 11-oct-2022: no additional information is available for this complaint.
Additional Manufacturer Narrative
Other, other text: the complaint sample was returned for evaluation.Visual inspection of the returned device by the unaided eye did not reveal any defects with the device.The device was leak tested; no leaks were detected.Based on limited information in the complaint description, it is unknown whether the complainant was using sterile water or air to inflate the cuff.If air is used, the cuff will deflate sooner than expected and allow air to pass around the tube, which may cause a whistling noise.The amount of sterile water used to inflate the cuff is unknown.If the cuff was overfilled, it could result in tracheomalacia, which may cause a vibrating noise.No manufacturing defect was identified with the returned device; the complaint was not confirmed.No corrective actions are planned at this time.Analysis is performed on complaint data and trends; further actions are taken, accordingly.There were no non-conforming reports (ncrs) initiated for the lot or anomalies identified in the device history record review.

• Brand Name: BIVONA CUSTOM TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15713920
• Report Number: 3012307300-2022-26605
• Device Sequence Number: 12412425
• Product Code: JOH
• UDI-Device Identifier: 15019517021028
• UDI-Public: 15019517021028
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: FT15AN35NSA151N
• Device Catalogue Number: FT15AN35NSA151N
• Device Lot Number: GA029959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2022
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 11/02/2022
• Supplement Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown