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

Model Number	FT21DN60NSA055N
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon will not inflate.No injury.
Additional Manufacturer Narrative
H10: device evaluation: the device was returned for investigation.Functional inspection of the two returned devices confirmed that the cuffs would not inflate.The devices were dissected and determined the blockage was due to the teflon tube that bridges the airway line to the lumen in the wall of the shaft being crimped / smashed.Custom devices are 200% leaked tested prior to packaging, which requires the cuffs to be inflated and deflated.Per the complaint description, the devices operated appropriately prior to being reprocessed.It is unknown how the teflon tube became crimped / smashed.No information was provided by the complainant as to how the tubes were reprocessed.Review of complaint investigations for custom devices that alleged inflation defects did not identify other complaints where the teflon tubes had been crimped / smashed.No adverse trends have been identified related to this issue.No corrective actions are planned at this time.Smiths medical regularly analyzes complaint data and trends and will take further actions accordingly.The customer stated problem was duplicated.The cause of the reported problem could not be determined.A dhr review was performed and no problems or issues were identified during this dhr review.

• Brand Name: BIVONA TRACHEOSTOMY TUBES
• Common Device Name: TRACHEOSTOMY TUBE AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14137756
• Report Number: 3012307300-2022-06554
• Device Sequence Number: 20394690
• Product Code: JOH
• UDI-Device Identifier: 15019517264609
• UDI-Public: 15019517264609
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2022

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
• Device Expiration Date: 09/03/2026
• Device Model Number: FT21DN60NSA055N
• Device Catalogue Number: FT21DN60NSA055N
• Device Lot Number: GA021309
• 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: 03/25/2022
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 04/18/2022
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2021
• 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