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

Model Number	CUSTOM 3.5 TTS FLEXTEND + 1/EA
Medical Device Problem Codes	Material Rupture (1546); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation results completed on a smiths medical slicone-bivona tube.The device was visually inspected and revealed the teflon tubing used to bridge the airway line to the lumen in the shaft had worked its way inside the pilot balloon.Device was able to inflate and deflate.The complaint was validated and root cause unknown as no lot number was revealed.Teflon tubing was in the correct location when the device was assembled; otherwise, the opening that joins the external airway line to the internal lumen would have been blocked by adhesive.The investigation could not determine a definitive root cause for the migration of the teflon tubing into the pilot balloon.Since no adverse trends have been identified related to this issue, no corrective actions are planned at this time.
Event or Problem Description
Information was received that smiths bivona® adult tts¿ tracheostomy tube reported during cleaning, a small piece of plastic was noticed coming out of the pilot line.The user was concerned over foreign body being ingested into the stoma.No patient adverse events reported and a new trach change took place.

• Brand Name: BIVONA ADULT TTS TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD,INC.; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 9845167
• Report Number: 3012307300-2020-01986
• Device Sequence Number: 765453
• Product Code: JOH
• UDI-Device Identifier: 15019517195507
• UDI-Public: 15019517195507
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: CUSTOM 3.5 TTS FLEXTEND + 1/EA
• Device Catalogue Number: FT19FN35NGE076S
• Device Lot Number: 3782497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Congenital Anomaly; Other; Required Intervention
• Patient Age: 14 MO
• Patient Weight: 8