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

Model Number	60P055
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during use, the customer found it difficult to insert the product into the patient.The customer also noticed that the patient had trouble discharging sputum.The customer checked the device and found a protrusion in it.The device was exchanged to resolve the issue with no patient injury.No patient injury.
Additional Manufacturer Narrative
Other, other text: one unit was returned for investigation.Upon physical inspection, it was found that the complained issue could not be duplicated and the device passed all functional tests.Dhr review was not completed as there was no lot number available.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: david halverson ; 6000 nathan lane north; 7-15-26 fukushima,; minneapolis, MN 55442
• MDR Report Key: 12725661
• Report Number: 3012307300-2021-10495
• Device Sequence Number: 1427925
• Product Code: BTO
• UDI-Device Identifier: 15021312005783
• UDI-Public: 15021312005783
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K912469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2023

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: Health Professional
• Device Model Number: 60P055
• Device Catalogue Number: 60P055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2021
• Supplement Date Received by Manufacturer: 11/25/2021; 06/15/2023
• Initial Report FDA Received Date: 10/31/2021
• Supplement Report FDA Received Date: 12/23/2021; 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown