MAUDE Adverse Event Report: BIVONA; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	ST14EN80NSC324N
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient becomes sore in the throat due to cuff not being centered.Leakage through the mouth is experienced as well because of this issue after the cuff is filled with sterile water.Before inserting the cuff, the cuff is always leak tested.No adverse patient effects were reported.

• Brand Name: BIVONA
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• MDR Report Key: 12716114
• Report Number: 3012307300-2021-10435
• Device Sequence Number: 4920772
• Product Code: JOH
• UDI-Device Identifier: 10351688787255
• UDI-Public: 10351688787255
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K923878
• 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): 10/28/2021

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: No Information
• Device Model Number: ST14EN80NSC324N
• Device Catalogue Number: ST14EN80NSC324N
• 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: 09/28/2021
• Initial Report FDA Received Date: 10/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: N
• Patient Sequence Number: 1
• Patient Age: 35 YR