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

Model Number	FT15LN90NSC861N
Medical Device Problem Codes	Defective Device (2588); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the customer has a defective trach.No adverse patient or clinical effects were reported by the customer.
Additional Manufacturer Narrative
B3: date of event and d4: udi section are 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 required.
Event or Problem Description
Additional information was received: event occurred at patients home.Defective trach cuff was in use at the time of discovery.Ventilator was alarming and air leak was noted.There was no patient injury.There was no additional medical intervention.Trach was changed out immediately.Trach tube was replaced.
Additional Manufacturer Narrative
(b)(6).Event problem device code, corrected data: b1, b2, h1, h6 - health impact codes.
Additional Manufacturer Narrative
Additional information is provided in h.2., and h.6.Two photographs were returned for evaluation.The first photo displays the product labeling.The second photo displayed the device?s cuff, which was partially deflated.The photos taken of the complaint sample did not include a magnified close-up of the cuff for evidence of any punctures or tears to determine the cause of the cuff deflation.Root cause could not be defined with confidence.All materials in the manufacturing process, as well as all finished good products are released to market based on approved quality specification.The product is released after the review of all acceptance of applicable documentation.There were no non-conformances or abnormalities found in the device history record review that would be linked to this issue.For all enquiries or follow-up questions related to the record, do not use (b)(6).

• Brand Name: BIVONA FLEXTEND TTS TRACHEOSTOMY TUBE
• 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: 16878193
• Report Number: 3012307300-2023-05197
• Device Sequence Number: 5718211
• Product Code: JOH
• UDI-Device Identifier: 15019517035322
• UDI-Public: 15019517035322
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2024

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: Other
• Device Model Number: FT15LN90NSC861N
• Device Catalogue Number: FT15LN90NSC861N
• Device Lot Number: ST014483
• Was Device Available for Evaluation?: No
• 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: 04/20/2023
• Supplement Date Received by Manufacturer: 12/08/2023; 03/04/2024
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 01/08/2024; 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2022
• 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 Age: 45 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: White