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

Model Number	60SN035
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product sample was received and is awaiting evaluation, investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that when changing the cannula it was discovered that it had a crack.A new cannula was used.There has been no report of observable clinical symptoms or a change in symptoms identified in the patient.
Event or Problem Description
E1 additional information provided for reporting facility.
Additional Manufacturer Narrative
Other, other text: a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
H3.Device evaluated by manufacturer and h6.Evaluation codes: updated.A returned sample was received in use condition without the original packaging.The returned sample was visually inspected at a distance of 12 to 16 inches and normal conditions of illumination.Per visual inspection, the tube was found to have a severe tear confirming the complaint.No further analysis was performed on the returned sample.Because damage was not present during the pre-use check a root cause could be due to improper use of the product.A device history record (dhr) review showed there were no issues or nonconformance's reported during the manufacturing of the reported lot number.No corrective actions taken since the root cause was improper use of the product.

• Brand Name: BIVONA TRACHEOSTOMY TUBES
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16636109
• Report Number: 3012307300-2023-03177
• Device Sequence Number: 15264850
• Product Code: JOH
• UDI-Device Identifier: 15021312000139
• UDI-Public: 15021312000139
• 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
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/05/2023

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: Lay User/Patient
• Device Expiration Date: 03/03/2026
• Device Model Number: 60SN035
• Device Catalogue Number: 60SN035
• Device Lot Number: 4122445
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/13/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2023
• Supplement Date Received by Manufacturer: 03/29/2023; 05/25/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 03/31/2023; 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2021
• 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
• Patient Sex: Unknown