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

Catalog Number	FT19DN50NSA006N
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tip of the silicone on the tracheostomy tube seemed to be unfinished and rough.The mother of the patient tried to put the tracheostomy tube in the patient but it made the patient cough.It was later observed that the device seemed to have two small rough bumps on one side.No patient injury or complications were reported in relation to this event.
Additional Manufacturer Narrative
Additional information was received indicating that the defective tube was attempted to be used but made the patient cough.So, the patient's back up tube was used with no further issue.One bivona customized flextend tracheostomy tube was returned for analysis.Visual inspection revealed a rough area to the distal end of the device.The device was inspected; passing all required specifications.It was found that the device likely shifted and touched another device in the lot during the drying operation; the adhesive causing the rough spot.Based on the evidence, the complaint was confirmed.The root cause was found to be due to manufacturing as the operator failed to identify the tactile defect in the adhesive.

• Brand Name: BIVONA
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9101906
• Report Number: 3012307300-2019-05126
• Device Sequence Number: 3185638
• Product Code: JOH
• UDI-Device Identifier: 15019517186833
• UDI-Public: 15019517186833
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2019

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 Expiration Date: 08/26/2024
• Device Catalogue Number: FT19DN50NSA006N
• Device Lot Number: DS031883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 09/22/2019
• Supplement Report FDA Received Date: 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 YR