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

Model Number	670185
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the cuff component of the bivona tracheostomy was found to be leaking after 72 hours of use.No patient injury or complications were reported in relation to this event.
Additional Manufacturer Narrative
Other, other text: device evaluation- two used devices were returned for evaluation.The returned devices were given leak testing; this showed leakage at the same area for both devices.The leak site was determined to be a cut area on the cuffs located approximately 25mm from the distal tip.Because the device is 100% leak tested prior to packaging it is unlikely this damage was present during manufacturing.The cuff damage was present on both samples in same area and were returned for separate events for the same patient (related file cc-0083933.It was determined likely the issue occurred when the cartilage in the patient's trachea rubbed against the cuff surface and eventually caused the cut damage.

• Brand Name: BIVONA
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10449253
• Report Number: 3012307300-2020-08442
• Device Sequence Number: 4031040
• Product Code: JOH
• UDI-Device Identifier: 15021312006087
• UDI-Public: 15021312006087
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K083641
• 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): 12/22/2020

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: 670185
• Device Catalogue Number: 670185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1