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

Model Number	67P035
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device's cuff was not inflating during pre-test despite filling with water.No adverse effects reported as a result of delay.
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during the device history record review.One sample was received in used conditions, without original packaging and with its certificate of safe handling.During the functional testing the sample was inflated with air, the cuff only inflated one side.According to the instruction for use the pilot balloon was manipulated, and the cuff inflated.After the whole cuff inflated, it was deflated and inflated 4 times, all the time the cuff inflated completely and symmetrically, based on analysis the complaint was not confirmed.Root cause could not be determined since the sample successfully passed functional test.No corrective actions were taken since the complaint was not confirmed.

• Brand Name: BIVONA TTS TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12587300
• Report Number: 3012307300-2021-09804
• Device Sequence Number: 3452306
• Product Code: JOH
• UDI-Device Identifier: 15021312006261
• UDI-Public: 15021312006261
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2023

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: Lay User/Patient
• Device Model Number: 67P035
• Device Catalogue Number: 67P035
• Device Lot Number: 4063164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown