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

Model Number	FT16EN35NGE061N
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms#: 617147.No lot number was provided; therefore, device history record review could not be completed.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection of the returned device using the unaided eye under normal plant lighting revealed that the teflon tubing used to bridge the airway line to the lumen in the shaft had worked its way inside the pilot balloon.The cuff of the returned device did inflate and deflate when air was inserted through the inflation valve, which indicates that the teflon tubing was in the correct location when the device was assembled; otherwise, the opening that joins the external airway line to the internal lumen would have been blocked by adhesive.The inflation valve was removed from the pilot balloon to facilitate removing the teflon tubing from the pilot balloon.The root cause of the reported issue was unable to be determined.The investigation could not determine a definitive root cause for the migration of the teflon tubing into the pilot balloon.Since no adverse trends have been identified related to this issue, no corrective actions are planned at this time.
Event or Problem Description
It was reported that a foreign object was found in the pilot balloon right out of the box.No patient injury was reported.

• Brand Name: BIVONA
• 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: 15607389
• Report Number: 3012307300-2022-24078
• Device Sequence Number: 2314712
• Product Code: JOH
• UDI-Device Identifier: 15019517055122
• UDI-Public: 15019517055122
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2022

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: FT16EN35NGE061N
• Device Catalogue Number: FT16EN35NGE061N
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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