MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TUBES NEO/PED TTS; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	67SN035
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#: (b)(4).A device history record review (dhr) was conducted which indicated all inspections were completed and no issues were noted during manufacture.Visual inspection revealed the sample was in used conditions, without original packaging and with its certificate of safe handling.During functional testing, the sample was filled with 5cc of air and when the sample was inflated with air, the cuff only inflated one side.According to the ifu (instructions for use) the pilot balloon was manipulated, and the cuff inflated.After the whole cuff inflated, it was deflated and inflated 4 times and all the times the cuff inflated completely and symmetrically, based on analysis the complaint is 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.
Event or Problem Description
It was reported that there was a pre-test cuff failure.No patient injury was reported.

• Brand Name: BIVONA TUBES NEO/PED TTS
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• 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: 16330709
• Report Number: 3012307300-2023-01061
• Device Sequence Number: 6817676
• Product Code: BTO
• UDI-Device Identifier: 15021312000252
• UDI-Public: 15021312000252
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/09/2023

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: Health Professional
• Device Expiration Date: 07/30/2020
• Device Model Number: 67SN035
• Device Catalogue Number: 67SN035
• Device Lot Number: 4015535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 02/08/2023
• 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): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown