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

Model Number	670190
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Customer noticed a hole in the cuff and therefore no water could be held in to block.This was noticed after two cleaning cycles.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: 11120864
• Report Number: 3012307300-2021-00111
• Device Sequence Number: 19846242
• Product Code: JOH
• UDI-Device Identifier: 15021312006094
• UDI-Public: 15021312006094
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K944178
• 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
• Report Date (Section B): 01/05/2021

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: 04/10/2023
• Device Model Number: 670190
• Device Catalogue Number: 670190
• Device Lot Number: 3600344
• 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: 12/08/2020
• Initial Report FDA Received Date: 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1