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

Model Number	FT19AN35NGE060S
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Irritation (1941)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the cuff of the custom smiths medical, trach tube was found asymmetrical which was found after it was noted that her pressures kept dropping and patient irritation.Patient was leaking air from her stoma.Bubbles were coming out of her mouth and air could be felt from her nose.Additional water was added to the cuff with no resolution.The trachs were changed each time to resolve the issue.No further adverse patient effects were reported.
Additional Manufacturer Narrative
H2: additional information: see d10.H3: two bivona tracheostomy tubes with cuffs were received in their original packaging.There were no abnormalities found during the visual inspection of the returned samples.Using a standard syringe, 5cc's of air was inserted into the airway lines of both returned devices.There were no issues identified with the cuffs inflating.A standard ruler was used to measure cuff symmetry on both devices.Measuring from the center of the shaft to the outside of the cuff, both devices measured at 8mm on one side and 9mm on the other side.The reported problem could not be confirmed.There was no fault found with the returned tubes.

• 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
• MDR Report Key: 10103698
• Report Number: 3012307300-2020-05340
• Device Sequence Number: 3572964
• Product Code: JOH
• UDI-Device Identifier: 15019517178043
• UDI-Public: 15019517178043
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 06/14/2024
• Device Model Number: FT19AN35NGE060S
• Device Catalogue Number: FT19AN35NGE060S
• Device Lot Number: DSO27576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2020
• Supplement Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 05/29/2020
• Supplement Report FDA Received Date: 07/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 20 MO
• Patient Weight: 9