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

Model Number	670160
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This remediation mdr was generated under protocol b10010116, as a result of warning letter cms#617147.A manufacturing device history review was not performed because the results of the complaint investigation do no indicate a problem with the manufacture of the device.A product sample was received for evaluation.Visual and functional testing were performed.During visual inspection, it was observed that the device was in used conditions, without the original packaging and with its certificate of safe handling.There were no particles, foreign material, cracks or any other adverse visual condition.A retain sample from the process was also visually inspected and there were no particles around connector, no foreign contamination and both samples are identical in terms of visual conditions.Therefore, the failure mode could not be confirmed.The instructions for use were reviewed and states, "devices used in or during inflation of the cuff must be clean and free from all foreign matter and must be removed from the inflation valve immediately after use; failure to do so may result in loss of cuff volume and inadequate ventilation?.The root cause of the reported issue could not be determined.No actions were taken.
Event or Problem Description
It was reported that every time the tracheostomy is received back from cleaning or to go to cleaning, secretions are found on the trach.The patient has chronic obstructive pulmonary disease and many secretions get encrusted on the tracheostomy.This has been seen at least 3 or 4 times.No patient injury was reported.

• Brand Name: BIVONA TUBES ADULT 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: 16316262
• Report Number: 3012307300-2023-00993
• Device Sequence Number: 8645788
• Product Code: JOH
• UDI-Device Identifier: 15021312006032
• UDI-Public: 15021312006032
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/08/2023

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 Model Number: 670160
• Device Catalogue Number: 670160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• 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: 01/31/2023
• Initial Report FDA Received Date: 02/07/2023
• 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