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

Catalog Number	CMZ3289N
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that when disconnecting a smiths medical (b)(4) custom tube from the iso connector, the iso connector detached from the rest of the cannula leaving no connection for the ventilator.A replacement cannula had to be inserted promptly.No further adverse patient effects were reported.
Additional Manufacturer Narrative
Device evaluation : one customized fixed fome tracheostomy tube was returned for evaluation.Immediate visual inspection detected a yellow tint on the device, which is typical with long term use.Further visual inspection of the device revealed the plastic reinforcement ring was missing from the end of the iso connector area of the silicone neckflange.Additionally, there was evidence of adequate adhesive applied to retain the plastic reinforcement ring within the silicone neck flange.The device instructions for use, states under section 8.0 (cleaning) that "the rotating 15mm connectors can only be removed from pediatric "v" flanges and pediatric flextend connector ends.All other flanges do not have removable rotating connectors.Attempting to remove the rotating or fixed connector in all other products could damage the tube." the returned device does not have a removable rotating connector.Furthermore, the device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified.Based on the evidence and evaluation, the complaint was confirmed.However, the investigation did not reveal any intrinsic manufacturing defects with the returned device.The investigation also concluded the split shaft was not due to a manufacturing defect, rather a result of user interface.

• Brand Name: BIVONA CUSTOM TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF, PRODUCT CODE: JOH
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8843385
• Report Number: 3012307300-2019-03833
• Device Sequence Number: 18892420
• Product Code: JOH
• UDI-Device Identifier: 15019517148688
• UDI-Public: 15019517148688
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: CMZ3289N
• Device Lot Number: DS015988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2019
• Supplement Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 11/05/2019
• 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: Required Intervention