MAUDE Adverse Event Report: BIVONA; TRACHEOSTOMY

Model Number	FT20GN60NSA036N
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medial bivona cuff was leaking.There was 1.8 ml of water instead of the required 3.4ml.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY
• MDR Report Key: 12342757
• Report Number: 3012307300-2021-08610
• Device Sequence Number: 17077761
• Product Code: BTO
• UDI-Device Identifier: 15019517235029
• UDI-Public: 15019517235029
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 08/19/2021

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: FT20GN60NSA036N
• Device Catalogue Number: FT20GN60NSA036N
• 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: 02/21/2021
• Initial Report FDA Received Date: 08/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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