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

Model Number	670185
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that the trach tube was set and found leaking after 2 days in use.The airway surface of the patient is confirmed smooth, which checked in hospital.No injury reported.
Additional Manufacturer Narrative
B3: date of event is unknown.No information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr, 803.56 when required.
Additional Manufacturer Narrative
Device evaluated by manufacturer, h3 - device evaluated by manufacturer, and h6 - evaluation code: updated device evaluation: two units were returned for investigation in used condition without original packaging.Visual inspection showed that the cuff in both samples were torn.Functional testing confirmed the complaint when both devices failed the leak test.According to the instructions for use the device is to be checked if the product has any damage after being used and cleaned for subsequent uses in the patient, the root cause could be due to improper use of the product.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.No actions taken at this time due to root cause being improper use.Complaints will continue to be monitored.
Event or Problem Description
Additional information received on 10-oct-2023 via email.The event date was updated from unknown to 26-apr-2023.
Additional Manufacturer Narrative
Updated.

• Brand Name: BIVONA TIGHT TO SHAFT TRACHEOSTOMY TUBE
• 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: 16881423
• Report Number: 3012307300-2023-05234
• Device Sequence Number: 7461106
• Product Code: JOH
• UDI-Device Identifier: 15021312006087
• UDI-Public: 15021312006087
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2023

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: Health Professional
• Device Expiration Date: 12/14/2025
• Device Model Number: 670185
• Device Catalogue Number: 670185
• Device Lot Number: 4089235
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/03/2023
• 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: 04/27/2023
• Supplement Date Received by Manufacturer: 06/28/2023; 10/10/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 06/30/2023; 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2021
• 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