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

Model Number	670185
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: one picture and one sample of smiths medical tracheostomy|silicone - bivona tubes adult tts was returned for analysis.In the picture received, it was noted that the valve was inside the pilot balloon and the original box.Visual inspection of the returned sample indicated that the valve was inside the pilot balloon.There were no short shots surrounding the opening in the pilot balloon that would have allowed the valve to fall out of position.Valve was removed from the pilot balloon and then assembled, inflated the units with 20cc of air, the cuffs inflated without problems.Based on the condition of the returned sample (i.E., used), the valve had to have been present for a period of time.The valve is press-fitted into the balloon and if it is accidently removed when using a syringe, it can be reinserted.Based on the evidence, the complaint was confirmed, and the problem source of the reported event is unknown.
Event or Problem Description
Information was received indicating that the patient presented for a tube change with a smiths medical tracheostomy|silicone - bivona tubes adult tts, as he felt like he was going to vomit when he fills the cuff with air rarely.It was also reported that it is believed that the issue was because they had been too forceful with instilling air/water.No patient injury was reported.No adverse effects were reported.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY TUBE AND TUBE CUFF
• MDR Report Key: 12512243
• Report Number: 3012307300-2021-09520
• Device Sequence Number: 6014456
• Product Code: JOH
• UDI-Device Identifier: 15021312006087
• UDI-Public: 15021312006087
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/22/2021

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 Expiration Date: 06/10/2024
• Device Model Number: 670185
• Device Catalogue Number: 670185
• Device Lot Number: 3801539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 09/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2019
• 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