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

Model Number	FT19LN60NGA888N
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This remediation mdr was generated under protocol(b)(4), as a result of warning letter cms#(b)(4).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.One device was received by manufacture for investigation; based on information provided by the complainant, the device was confirmed to have been built in that manufacture.The product was subject to a leak test after being inflated with air and was confirmed to exhibit a leak originating from the middle of the posterior side of the cuff when in situ.Magnification showed that there was a tiny hole (a pinhole) in the cuff that could not be seen by the unaided eye.Devices are leak tested: once by manufacturing and once during a final quality assurance inspection immediately prior to packaging.No leaks were identified prior to packaging.No sharp objects were identified in the packaging area that could have contributed to damage the cuff.The root cause of the reported issue could not be determined.No additional corrective action is planned at this time.Complaint information will continue to be monitored and assessed for trends, which could lead to further corrections or corrective actions being deemed necessary.
Event or Problem Description
It was reported that the cuff would not inflate during pre-test.No patient injury was reported.

• Brand Name: BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
• 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): 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: 16226191
• Report Number: 3012307300-2023-00616
• Device Sequence Number: 20171018
• Product Code: JOH
• UDI-Device Identifier: 15019517215823
• UDI-Public: 15019517215823
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2023

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: Lay User/Patient
• Device Expiration Date: 02/11/2026
• Device Model Number: FT19LN60NGA888N
• Device Catalogue Number: FT19LN60NGA888N
• Device Lot Number: ST002764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown