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

Model Number	670175
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a cuff leak was discovered during pre-test after reprocessing when product was about to be reinstalled into patient.No injury was reported.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Device evaluated by manufacturer and h6.Health impact, and evaluation codes: updated.One device was received in used condition without the original packaging.Visual inspection detected that the cuff had damage (tear).A leak test was performed to confirm the defect in the sample, the sample failed the test confirming the complaint and a root cause was due to improper use of the product.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, ADULT
• 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; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16438851
• Report Number: 3012307300-2023-01659
• Device Sequence Number: 16943640
• Product Code: JOH
• UDI-Device Identifier: 15021312006063
• UDI-Public: 15021312006063
• 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
• Report Date (Section B): 06/30/2023

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 Model Number: 670175
• Device Catalogue Number: 670175
• Device Lot Number: 4276388
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/16/2023
• 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: 02/04/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2022
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian