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

Model Number	FT22AN35NGF963N
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 during a pre-use check the cuff would not inflate.No patient involvement was reported.
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 found the the blockage was due to the teflon tube that bridges the airway line to the lumen in the wall of the shaft created an obstruction.Functional testing found the returned device cuff would not inflate.It is unclear how or when the blockage came into being, however it is highly unlikely that this condition was present prior to leaving the facility due to the two separate leak tests that were confirmed to be passing.The root cause of the issue could not be determined.No corrective actions are planned at this time.As a correction, manufacturing personnel will be alerted to this issue for awareness.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken accordingly.

• Brand Name: BIVONA TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY 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: 14245994
• Report Number: 3012307300-2022-07123
• Device Sequence Number: 17327572
• Product Code: JOH
• UDI-Device Identifier: 15019517291773
• UDI-Public: 15019517291773
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• 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): 07/08/2022

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 Model Number: FT22AN35NGF963N
• Device Catalogue Number: FT22AN35NGF963N
• Device Lot Number: ST011145
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/22/2022
• 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: 04/12/2022
• Supplement Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2022
• 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
• Patient Sex: Unknown