MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA NEONATAL AND PEDIATRIC TTS TRACHEOSTOMY TUB; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	67SP035
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2023
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 reportable information becomes available.
Event or Problem Description
It was reported that during a pre-use check the cuff did not fully inflate despite "significant" air added and manipulation of the cuff.Protocol was used and 10 ml off air added to the cuff.Cuff was massaged as directed and not all of the cuff inflated.Procedure performed was routine tracheostomy change.Event occurred while testing.
Additional Manufacturer Narrative
H6: event methods, evaluation, and conclusion codes: updated.One device was received for investigation.During visual inspection no damage or anomalies were observed on the device.The device was functionally tested by inflating the cuff while manipulation the cuff, and the device balloon inflated as intended.Based on the results of the inspection and testing, the investigation could not confirm the reported issue or assign a root cause.A review of manufacturing device history records found no discrepancies or anomalies.As no manufacturing root cause was identified, no actions have been assigned at this time.

• Brand Name: BIVONA NEONATAL AND PEDIATRIC TTS TRACHEOSTOMY TUB
• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 17099410
• Report Number: 3012307300-2023-06140
• Device Sequence Number: 7690764
• Product Code: JOH
• UDI-Device Identifier: 15021312000719
• UDI-Public: 15021312000719
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (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): 08/09/2023

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: Health Professional
• Device Expiration Date: 09/16/2025
• Device Model Number: 67SP035
• Device Catalogue Number: 67SP035
• Device Lot Number: 4051662
• 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): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2023
• Supplement Date Received by Manufacturer: 07/22/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2020
• 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