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

Model Number	FT20LN35NGF003N
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a hole in the pilot bulb was found.
Additional Manufacturer Narrative
Other, other text: returned device was received for evaluation.During the evaluation of the device the customer reported condition was not confirmed.No fault found.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
Event or Problem Description
A hole in the pilot bulb was found.
Additional Manufacturer Narrative
Other, other text: this mdr was generated under protocol b10010116, as a result of warning letter cms# (b)(4).A manufacturing device history record (dhr) review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.A product sample was received for evaluation.Visual and functional testing were performed.Physical condition of the device was examined by the naked eye under normal lighting, no defects were identified.Leak test was conducted to see if there were any functional problem.A leak was detected in the pilot balloon.There was an approximately 1 mm cut in the pilot balloon, which was located at the end of the inflation valve.The root cause of the reported issue was not determined.Devices are 200 percent inspected for leaks prior to packaging: once by manufacturing and once by quality.If the cut was present, it would have been detected during the leak tests.Due to the location of the cut, a force may have been applied to the balloon or the balloon was trapped between objects, which could have caused the inflation valve to pierce the balloon.Actions taken to mitigate the reported: no adverse trends have been identified related to this issue.No corrective actions are planned at this time.If the occurrence of this issue increases significantly, additional investigative action will be taken.Additional information provided in d4, h2.

• Brand Name: BIVONA
• 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): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13020315
• Report Number: 3012307300-2021-12947
• Device Sequence Number: 4976696
• Product Code: JOH
• UDI-Device Identifier: 15019517249910
• UDI-Public: 15019517249910
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/22/2022

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 Model Number: FT20LN35NGF003N
• Device Catalogue Number: FT20LN35NGF003N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/16/2021
• Supplement Date Received by Manufacturer: 02/15/2022; 12/19/2022
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 03/18/2022; 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 16 MO
• Patient Sex: Male
• Patient Weight: 7 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American