MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	670190
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer contact phone number: (b)(6).Device evaluation in progress.
Event or Problem Description
It was reported that the cuff component of bivona tracheostomy tube was not inflating.The plastic in the pilot balloon was jammed.The tracheostomy tube was changed as a result.The patient was reported to be in good condition.
Additional Manufacturer Narrative
Device evaluation- one sample was returned for evaluation.During examination of the sample, the valve was found inside of the pilot balloon.No molding issues were identified.The investigator removed the valve and reassembled the valve back on to the device as per bonding procedure.A syringe was used to inflate the cuff.No issues were found with the inflation line or the cuff after the valve had been reassembled.During production, the inflation valve is assembled into the pilot balloon.After this production step, the devices are 100% visually inspected and tested for leakage.If the valve damage had been present during production, no testing would have been possible.During investigation, the device issue was confirmed.The cause of the valve damage was not established but it could not be attributed to a manufacturing problem.

• Brand Name: BIVONA
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 11752909
• Report Number: 3012307300-2021-03633
• Device Sequence Number: 4138827
• Product Code: JOH
• UDI-Device Identifier: 15021312006094
• UDI-Public: 15021312006094
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 670190
• Device Catalogue Number: 670190
• Device Lot Number: 4002277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2021
• Supplement Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 08/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening