MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	60P045
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Expiration date and manufacture date are unknown, no information is available based on reported lot number.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 the bivona flextend 4.5mm ped uncuffed trach tube flange broke, causing patient to decannulate.There has been no report of observable clinical symptoms or a change in symptoms identified in the patient.
Additional Manufacturer Narrative
No product was returned.We are unable to confirm the reported complaint.If the product is returned, icu medical will reopen this complaint for further investigation.A review of the device of the device history records could not be completed as no lot number was provided by the customer.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• 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: 16610953
• Report Number: 3012307300-2023-03003
• Device Sequence Number: 11994762
• Product Code: BTO
• UDI-Device Identifier: 15021312005769
• UDI-Public: 15021312005769
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K912469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 60P045
• Device Catalogue Number: 60P045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2023
• Supplement Date Received by Manufacturer: 06/27/2023; 07/05/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 06/27/2023; 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 19 MO
• Patient Sex: Male
• Patient Weight: 10 KG
• Patient Ethnicity: Hispanic