MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SILICONE - BIVONA TUBES NEO/PED TTS; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	67SN035
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Four pictures and two samples were received for evaluation.Visual and functional testing were performed.Visual inspection found they were in used condition, without the original packaging and with the certificates of safe handling.During functional testing, the samples were inflated with air, the cuffs only inflated on one side.The pilot balloons were manipulated and the cuffs inflated.After the cuffs inflated, they were deflated and inflated four times.The cuffs inflated completely and symmetrically; based on analysis the complaint is not confirmed.The root cause of the issue could not be determined.No actions were taken since the complaint was not confirmed.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken.
Event or Problem Description
It was reported that two tracheostomies will not inflate during pre-testing.No patient injury was reported.

• Brand Name: SILICONE - BIVONA TUBES NEO/PED TTS
• 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: 16060739
• Report Number: 3012307300-2022-28193
• Device Sequence Number: 2033372
• Product Code: JOH
• UDI-Device Identifier: 15021312000252
• UDI-Public: 15021312000252
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/28/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/16/2025
• 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: 09/22/2021
• 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: 12/19/2022
• Initial Report FDA Received Date: 12/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2020
• 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