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

Model Number	67PFS40
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cuff on a smiths medical trach tube hasn't been inflating correctly.The cuff sticks on one side despite adding more sterile water.This leads to constant issues with a large air leak and not getting proper volumes creating work of breathing difficulties.No adverse patient effects were reported.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 11758497
• Report Number: 3012307300-2021-03659
• Device Sequence Number: 3192016
• Product Code: JOH
• UDI-Device Identifier: 10351688518620
• UDI-Public: 10351688518620
• 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
• Report Date (Section B): 05/01/2021

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 Expiration Date: 10/14/2022
• Device Model Number: 67PFS40
• Device Catalogue Number: 67PFS40
• Device Lot Number: 3509836
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1