MAUDE Adverse Event Report: NULL BIVONA; TRACHEOSTOMY TUBE, NON-REINFORCED, NON-CUSTOMIZED

Model Number	FT14JN45NSF326N
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspection were completed and no issues were noted during manufacture.One customized 4.5mm i.D.Flextend tracheostomy tube with swivel connector and tts cuff was returned for the valve got pushed inside the pilot balloon while inflating the cuff.The device was visually inspected for the position of the valve and it is seated where it should be.The device was then inflated using air.The cuff inflated accordingly and there were no leaks present.The device appears to function as intended and unable to confirm the allegation.The dhr was reviewed and found no abnormalities.The product is 100% inspected and leak tested during manufacturing, prior to shipping to the customer.Per the dhr review, the device passed qa inspection.Report source unknown.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that one of the custom tubes was defective: no patient injury was reported.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY TUBE, NON-REINFORCED, NON-CUSTOMIZED
• Manufacturer (Section G): NULL
• MDR Report Key: 15437055
• Report Number: 3012307300-2022-19407
• Device Sequence Number: 5581644
• Product Code: JOH
• UDI-Device Identifier: 10351688825407
• UDI-Public: 10351688825407
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2022

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: Lay User/Patient
• Device Expiration Date: 02/02/2026
• Device Model Number: FT14JN45NSF326N
• Device Catalogue Number: 118112924
• Device Lot Number: GA015024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2021
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown