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

Model Number	60PFS35
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Expiration date and manufacture date are unknown, no information is available based on reported lot number.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that post reprocessing of the tube a discoloration of the silicone immediately below the flange area (yellow tinge) is noted.The more times we reprocess the tubes the discoloration becomes more pronounced.There has been no report of patient injury or no observable clinical symptoms or a change in symptoms identified in the patient.
Additional Manufacturer Narrative
Device evaluation: one device was received for investigation.Upon visual inspection, the color change in the tube was identified, slightly yellow areas can be seen.The complaint was confirmed.Based on the analysis performed the condition was reported after reprocessing the product.Initially the discoloration was not present during the pre-use check, the instructions for use indicate that the product should be stored and cleaned with precaution.The root cause could be due to improper use of the product.No lot number was provided therefor no device history report (dhr) review could be completed.No corrective actions are required since the root cause for discoloration of the product is for improper use of the product.

• Brand Name: BIVONA TRACHEOSTOMY TUBES
• 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): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16576744
• Report Number: 3012307300-2023-02728
• Device Sequence Number: 14984145
• Product Code: JOH
• UDI-Device Identifier: 15021312005851
• UDI-Public: 15021312005851
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2023

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: 60PFS35
• Device Catalogue Number: 60PFS35
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/08/2023
• 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: 02/28/2023
• Supplement Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 03/20/2023
• Supplement Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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