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

Model Number	ST16FN70NSC142N
Medical Device Problem Code	Ventilation Problem in Device Environment (3027)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical bivona trach was leaking air and mucus and the other trach gives the patient pain.The trach that was giving pain was taken out and the pain was gone.After a week, the trach that was giving pain was reinserted and gave pain again.
Event or Problem Description
Device evaluation in h10.
Additional Manufacturer Narrative
Other text: two customized 7.0mm i.D.Fixed tracheostomy tubes with swivel connector and tts cuff were returned due to claim that one device leaked and the other device caused the patient pain.Both devices were visually inspected and no abnormalities were found.The device od's were measured and found to be within specification.Next both shaft curves were inspected against the template tlg-tmp-018-2 (7.0mm) for the shaft curvature and both were within specification.The device cuffs were then inflated with air and leak tested in accordance with wi-10-012.Both cuffs inflated properly and neither had any leaks or air bubbles.Cannot confirm the allegation.See attached photos.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 11396660
• Report Number: 3012307300-2021-01641
• Device Sequence Number: 13744392
• Product Code: JOH
• UDI-Device Identifier: 15019517061093
• UDI-Public: 15019517061093
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2021

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: ST16FN70NSC142N
• Device Catalogue Number: ST16FN70NSC142N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1