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

Model Number	ZT20BN85ZSZ081N
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the red connection of the foamcuff got loose from the tube.No adverse patient effects were reported.
Additional Manufacturer Narrative
Device evaluation results: one bivona tracheostomy tube was returned for investigation in used condition.There has been only one lot manufactured for the provided part number, zt20bn85zsz081n.One device was built and shipped on 11 march 2020.A review of the only device history review (dhr) for the provided part number determined that the returned device was not zt20bn85zsz081n, but the complainant's previous part number zz18bn85zzz121n, which had been manufactured multiple times with the last lot being manufactured in december of 2019.The provided part number haf a swivel connector, a different curve and a larger proximal foam cuff than the device that was returned.The returned device had a spt connector, a standard curve, and a smaller proximal cuff.Visual inspection of the proximal-cuff airway line confirmed that the red wing plug was missing.There was evidence of adhesive and remnants of red silicone (red wing plug) still attached to the airway line.Based on the examination of the airway line, the investigation determined that the red plug was torn from the airway line and did not pull off due to lack of adhesive or the presence of paraylene coating on the portion of the airway line that was inserted into, and attached to the red wing plug.The customer reported product problem was confirmed and attributed to a user issue.This was established as the root cause.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 10767881
• Report Number: 3012307300-2020-10894
• Device Sequence Number: 2113826
• Product Code: JOH
• UDI-Device Identifier: 15019517221763
• UDI-Public: 15019517221763
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2021

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 Model Number: ZT20BN85ZSZ081N
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 11/01/2020
• Supplement Report FDA Received Date: 01/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1