MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA ADULT TTS ADJUSTABLE NECK FLANGE HYPERFLEX; TRACHEOSTOMY TUBE AND TUBE CUFF

Model Number	67HA70
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Codes	Pulmonary Dysfunction (2019); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2022
Type of Reportable Event	Serious Injury
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 the ring was well tightened but it was slipping which made the tracheostomy come out.The patient has a pulmonary pathology that has led to a failure of intubation and therefore to an emergency tracheostomy.Patient had to be sedated over the long term to avoid decanulation.Having a granuloma in the trachea, when the tracheostomy came out, it came up against the granuloma preventing any ventilation.Patient had several fibroscopies to urgently put the cannula back in place.The cannula had to be maintained by adhesives.
Event or Problem Description
Additional information received confirming there were no clinical consequence observed, resolved with re-cannulation.
Additional Manufacturer Narrative
Device evaluation: one device was received for investigation.No damage or anomalies were observed during visual inspection.The device was functionally tested to verify its fastening mechanisms, and the device passed this testing and remained secure within specification.Manufacturing device history records were reviewed for the reported lot number, and no discrepancies or anomalies were identified.Based on the testing and available information, the investigation could not confirm the reported issue or identify a root cause.No actions have been assigned at this time.

• Brand Name: BIVONA ADULT TTS ADJUSTABLE NECK FLANGE HYPERFLEX
• Common Device Name: TRACHEOSTOMY TUBE AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15262625
• Report Number: 3012307300-2022-15726
• Device Sequence Number: 5634041
• Product Code: JOH
• UDI-Device Identifier: 15021312013801
• UDI-Public: 15021312013801
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K081440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 67HA70
• Device Catalogue Number: 67HA70
• Device Lot Number: 4240200
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/16/2022
• 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: 07/22/2022
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2022
• 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