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

Catalog Number	67HA70
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that leakage was found when the tracheostomy tube was in use with patient on the 16th day of use.This problem was solved by replacing with a new bivona 67ha70.The operator of the device was a health professional.There was patient involvement and unknown patient harm/adverse event reported.
Additional Manufacturer Narrative
D4.Lot number, expiration date, and h4.Manufacture date are unknown; no information has been provided to date.D4.Primary udi number: the primary di# has been used as the lot/serial information is unknown.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.
Additional Manufacturer Narrative
Investigation summary: the affected device was returned for evaluation.Visual inspection by the unaided eye under normal plant lighting revealed abraded marks on the underside of the shaft.Using a verified ruler (black dot), the abraded marks were located approximately 6 mm away from the inflation line and 19 mm from the distal tip of the shaft.The device was leak tested.A leak was detected emitting from the area where the abraded marks were located.The returned device appeared to have rubbed against something sharp either inside or outside the trachea.The investigation did not identify a manufacturing defect with the returned device.A device history record could not be completed as no lot number was received.

• Brand Name: BIVONA TTS ADJUSTABLE FLANGE HYPERFLEX TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 w 23rd ave; gary IN 46406
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19982589
• Report Number: 1824231-2024-00073
• Device Sequence Number: 14143292
• Product Code: JOH
• UDI-Device Identifier: 15021312013801
• UDI-Public: (01)15021312013801
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K081440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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 Catalogue Number: 67HA70
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/06/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown