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

Catalog Number	60NFPS40
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
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 information becomes available.
Event or Problem Description
It was reported that the tracheostomy tube had a torn flange.Patient status at this time is unknown, no harm was reported.Patient had tracheoesophageal fistula and esophageal atresia with significant tracheomalacia.
Additional Manufacturer Narrative
Investigation summary: the affected device was returned for evaluation.During the visual inspection, it was identified that flange had a cut near the tube.The broken flange issue is confirmed.No root cause established.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.

• Brand Name: BIVONA TRACHEOSTOMY TUBES
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19726446
• Report Number: 9617604-2024-00572
• Device Sequence Number: 20905630
• Product Code: JOH
• UDI-Device Identifier: 15021312516708
• UDI-Public: (01)15021312516708(17)261116(10)4221341
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

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 Catalogue Number: 60NFPS40
• Device Lot Number: 4221341
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 17 MO
• Patient Sex: Female
• Patient Weight: 7 KG