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

Catalog Number	CMZ2052N
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that the bivona tracheostomy tube had the incorrect curvature of the cannula.No reported adverse effects.
Additional Manufacturer Narrative
One silicone - bivona tube was returned for analysis.The returned device was reviewed according to the customized tier 1 template specifications and also to the customized drawing.The device shaft is formed using wet tubing and a customized forming rod for the specific patient.The forming rod noted in the dhr that was used was the correct rod for this order.The device was then placed against the manufacturing drawing mentioned above.When the neck flange is flush, the curvature of the device does extend past the allowable +/-1 degree tolerance.This may occur when the shaft is positioned inside the neck flange during manufacturing, it is not positioned at the correct location creating the radius of the curve to be slightly too close or too far from the neck flange resulting in the curve being out of spec.

• Brand Name: BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
• 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: 7611379
• Report Number: 3012307300-2018-02461
• Device Sequence Number: 1513019
• Product Code: JOH
• UDI-Device Identifier: 15019517124095
• UDI-Public: 15019517124095
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K923878
• 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): 07/16/2019

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: No Information
• Device Expiration Date: 02/14/2023
• Device Catalogue Number: CMZ2052N
• Device Lot Number: DS013691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 06/18/2018
• Supplement Report FDA Received Date: 07/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1