MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA NEONATAL AND PEDIATRIC TTS (TIGHT-TO-SHAFT; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	67SN035
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cuff does not inflate when checked before changing the needle.The device was returned to smiths medical.
Additional Manufacturer Narrative
The device was returned to smiths medical.The pilot balloon was manipulated, and the cuff inflated.After the whole cuff inflated, it was deflated and inflated 4 times, all the times the cuff inflated completely and symmetrically, based on analysis the complaint is not confirmed.Dhr: a device history review was also conducted on the component lot numbers and no discrepancies were found.
Additional Manufacturer Narrative
The device was returned to smiths medical.The pilot balloon was manipulated, and the cuff inflated.After the whole cuff inflated, it was deflated and inflated 4 times, all the times the cuff inflated completely and symmetrically, based on analysis the complaint is not confirmed.Dhr: a device history review was also conducted on the component lot numbers and no discrepancies were found.
Event or Problem Description
It was reported that the cuff does not inflate when checked before changing the needle.The device was returned to smiths medical.

• Brand Name: BIVONA NEONATAL AND PEDIATRIC TTS (TIGHT-TO-SHAFT
• 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): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13508864
• Report Number: 3012307300-2022-03162
• Device Sequence Number: 5147981
• Product Code: JOH
• UDI-Device Identifier: 15021312000252
• UDI-Public: 15021312000252
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/10/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 67SN035
• Device Catalogue Number: 67SN035
• Device Lot Number: 4016044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• 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: Not provided
• Initial Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown