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

Model Number	ST20GN40NGF026N
Medical Device Problem Codes	Break (1069); Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the trach tube in situ when inner lumen noticed to have a material?similar to radio-opaque line migrating into airway.Patient ventilated full time and was unstable at the time the issue was noticed.Due to high-risk patient's unstable airway, the ent changed the tube.No injury or impact on patient status occurred.
Additional Manufacturer Narrative
One unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.Foreign material was under the cuff.The problem source is unknown.Dhr review was not performed since no lot number was provided.
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection of the returned device revealed a substance under the cuff.When the cuff was inflated, the substance moved locations indicating that it was loose and not embedded.Using a razor blade, the cuff was cut and the substance removed.Using magnification, the substance appeared to be lint fibers.It is unclear as to the origin of the fibers, but were likely introduced into the inflation line via the liquid used to inflate the cuff.The instruction for use states under setup to use sterile water to inflate the cuff.No adverse trends have been identified related to this issue.No corrective actions are planned at this time.

• Brand Name: BIVONA TUBES CUSTOM
• Common Device Name: TRACHEOSTOMY TUBE AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13453576
• Report Number: 3012307300-2022-02450
• Device Sequence Number: 17356951
• Product Code: JOH
• UDI-Device Identifier: 15019517234886
• UDI-Public: 15019517234886
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ST20GN40NGF026N
• Device Catalogue Number: ST20GN40NGF026N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2022
• Supplement Date Received by Manufacturer: 02/15/2022; 02/16/2023
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 03/17/2022; 04/20/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown