MAUDE Adverse Event Report: BIVONA; TRACHEOSTOMY

Model Number	755170
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical cuff leaked.No patient adverse events reported.
Additional Manufacturer Narrative
No device was returned for investigation.Report was closed as no device returned.
Event or Problem Description
Cuff leak.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY
• MDR Report Key: 12263510
• Report Number: 3012307300-2021-07946
• Device Sequence Number: 11885978
• Product Code: JOH
• UDI-Device Identifier: 15021312006476
• UDI-Public: 15021312006476
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K914088
• 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,Followup
• Report Date (Section B): 10/20/2021

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: 10/29/2025
• Device Model Number: 755170
• Device Catalogue Number: 755170
• Device Lot Number: 4033779
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 10/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1