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

Model Number	67HA80
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the junction of pilot balloon was found broken and caused leakage during pre-test.No patient involvement.
Additional Manufacturer Narrative
Other, other text: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection did not reveal a defect with the returned device.Functional testing found no evidence of a leak was present.The investigation could not replicate the alleged defect.Device passed all functional testing.No problem found.Root cause cannot be determined as the sample was successfully tested and no discrepancies were detected.

• 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): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14239701
• Report Number: 3012307300-2022-07066
• Device Sequence Number: 4887446
• Product Code: JOH
• UDI-Device Identifier: 15021312013818
• UDI-Public: 15021312013818
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K081440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2022

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: 09/22/2025
• Device Model Number: 67HA80
• Device Catalogue Number: 67HA80
• Device Lot Number: 4015637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/31/2022
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2020
• 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