MAUDE Adverse Event Report: BIVONA; TRACHEOSTOMY TUBE

Model Number	67PFS30
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a smiths medical trach tube had an unknown issue.No adverse patient effects were reported.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY TUBE
• MDR Report Key: 12724699
• Report Number: 3012307300-2021-10471
• Device Sequence Number: 17267775
• Product Code: JOH
• UDI-Device Identifier: 10351688518606
• UDI-Public: 10351688518606
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 67PFS30
• Device Catalogue Number: 67PFS30
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 10/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1