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

Model Number	850170
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the complaint pictures showed that the wing on the inflation plug was torn, which created an opening in the plug where air could escape.Devices are 100% leak tested by manufacturing and a 20-piece sample are leaked tested by quality immediately prior to packaging.If the tear was present, the device would not have passed the leak test.A two-year review of complaints for fome cuff products identified only one other complaint for a tear in the red wing plug, which was received in august of 2018.No corrective actions are planned at this time.Smiths medical regularly analyzes complaint data and trends and will take further actions accordingly.The fault of the complaint could not be traced to manufacturing.Initial reporter occupation: sachbearbeiterin interne logistik.
Event or Problem Description
Information was received indicating that a smiths medical trach was head to be hissing from the cuff while in a patient.While cleaning, it was noticed that the valve adaptor of the cuff was cracked.There were no reported adverse events.

• 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
• MDR Report Key: 11067407
• Report Number: 3012307300-2020-12721
• Device Sequence Number: 14513378
• Product Code: JOH
• UDI-Device Identifier: 15021312006780
• UDI-Public: 15021312006780
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K913859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/23/2020

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: 850170
• Device Lot Number: 3890356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1