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

Model Number	65SN025
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Date of Event	04/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: lot number, expiration date and h4: device manufacture date 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 additional reportable information becomes available.
Event or Problem Description
It was reported that a tracheostomy was noted to be "out when end tidal reading disappeared".A tear found in tracheostomy cuff.The trach was replaced by respiratory therapy and provider.No adverse patient effects were reported by the customer.
Additional Manufacturer Narrative
One device was received for investigation.The reported issue was confirmed during visual inspection, which found damage in the cuff area of the component.No product lot number was provided, therefore, no review of manufacturing device history records could be conducted.Based on the available information and sample evaluation, the investigation confirmed the complaint, and attributed the root cause to user interface.No actions have been assigned at this time.

• 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: 16899318
• Report Number: 3012307300-2023-05430
• Device Sequence Number: 5561728
• Product Code: JOH
• UDI-Device Identifier: 15021312000016
• UDI-Public: 15021312000016
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 65SN025
• Device Catalogue Number: 65SN025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/03/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown