MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. DISP BIVONA NEO/PED TRACHEOSTOMY TUBES; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	60SP055
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the flange had split at the eyelet.This was the tubes first use - it had been in for 29 days.There was patient involvement.There was no patient harm as a result of this event.
Additional Manufacturer Narrative
H3: device has not been returned to date.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
One device was received for investigation.The reported issue was confirmed during visual inspection which confirmed that the device eyelet was split.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.However, the investigation determined that the issue likely occurred as a result of a manufacturing error.Complaint information will continue to be monitored and actions assigned accordingly.

• Brand Name: DISP BIVONA NEO/PED TRACHEOSTOMY TUBES
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minnepaolis, MN 55442 ; 2247062300
• MDR Report Key: 20034329
• Report Number: 3012307300-2024-07938
• Device Sequence Number: 20438965
• Product Code: BTO
• UDI-Device Identifier: 15021312000436
• UDI-Public: (01)15021312000436(17)280805(10)4414739
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K912469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2025

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 Catalogue Number: 60SP055
• Device Lot Number: 4414739
• 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: 07/29/2024
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2023
• 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 Sex: Unknown