MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA ADULT TIGHT TO SHAFT SILICONE TRACHEOSTOMY TUBE, CUFFED; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	670170
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: photos and one used unit were received for evaluation.The provided pictures by the complainant were reviewed.Visual inspection of the returned device by the unaided eye and under normal plant lighting reveal discoloration on the shaft below the neck flange.Using an iso taper gage, the taper of the connector was checked.It was deemed to be compliant with iso 5356-1.Using a caliper the flange od was measured to be 18.92, which is within manufacturing tolerance of 18.9 - 19.1 mm.Using the same caliper the clip id was measured to be 12.91 mm, which is within the tolerance of 12.9-13.1 mm.Using the caliper, three od measurements were taken along the iso tapper: 15.00 mm, 15.30 mm and 15.50 mm.The length of the connecter from the ledge to the top of the recessed clip area was 15.05 mm.No other complaints have been investigated for an iso taper failure for this lot of (b)(4) pieces produced in december 2022.The investigation determined that the connector met the print diso-sp1-00-2 rev 100.The investigation could not confirm the complaint or why the iso connector failed the complainant's gage.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.
Event or Problem Description
It was reported that the iso coupling was too small, and speaking valves and hme cassettes would not stick when using an inner cannula.There was no patient involvement and no harm/adverse event reported.

• Brand Name: BIVONA ADULT TIGHT TO SHAFT SILICONE TRACHEOSTOMY TUBE, CUFFED
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19082000
• Report Number: 3012307300-2024-02353
• Device Sequence Number: 8229490
• Product Code: JOH
• UDI-Device Identifier: 15021312006056
• UDI-Public: (01)15021312006056(17)271129(10)4346816
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 04/10/2024

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: Health Professional
• Device Catalogue Number: 670170
• Device Lot Number: 4346816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown