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

Model Number	FT21IN50NGF104N
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the trach was deflating after insertion.Due to this, the trach was removed from the patient to be tested.Once the trach was removed, it was filled and left out to see if it would stay inflated.It did not.No patient harm was reported at this time.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Three (3) product samples were received for evaluation.Visual and functional testing were performed.Visual inspection did not identify any anomalies.Functional testing found no leaks were detected in one of the returned samples.A slow inside leak was detected in two of the returned samples.The root cause of the reported issue was found to be insufficient adhesive inserted into the lumen above where the airway line is secured to the lumen on the two samples that leaked.A quality alert was issued to the production floor for custom lab operator review.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY TUBE 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: 14492838
• Report Number: 3012307300-2022-09575
• Device Sequence Number: 20381263
• Product Code: JOH
• UDI-Device Identifier: 15019517281057
• UDI-Public: 15019517281057
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/03/2022

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 Model Number: FT21IN50NGF104N
• Device Catalogue Number: FT21IN50NGF104N
• Device Lot Number: GA025476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/27/2022
• Supplement Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 05/24/2022
• Supplement Report FDA Received Date: 08/03/2022
• 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 Sex: Unknown