MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES); TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	60P055
Medical Device Problem Codes	Degraded (1153); Material Discolored (1170); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation in progress.
Event or Problem Description
It was reported that the surface of the inserted part of the tracheal cannula changed by becoming rough and discolored within 1-2 weeks of use.No death or serious injury was reported in connection with this incident.
Additional Manufacturer Narrative
One portex® bivona® uncuffed tracheostomy tube was returned for analysis in a used condition.The trach tube was noted to have yellow spots on it upon visual examination.The tube was attempted to be cleaned with a paper towel and the brown substance was transferred to the towel.Relevant documents were reviewed and considered adequate.A review of the manufacturing process was conducted and found that all procedures are being carried out appropriate.The training was reviewed and it was confirmed that the personnel had the trainings up to date.Verification of 32 assemblies were reviewed to see the complete manufacturing process and to review the visual inspections for contaminations.The units are reviewed 100% for foreign matter.Based on the evidence, the most likely cause of contamination occurred once it left shm since manufacturing performs a 100% inspection of the device for contaminations in different parts of the process and quality performs an inspection on a representative sample of each lot.

• Brand Name: BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES)
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7687400
• Report Number: 3012307300-2018-02683
• Device Sequence Number: 16472845
• Product Code: JOH
• UDI-Device Identifier: 15021312005783
• UDI-Public: 15021312005783
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K912469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2018

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: No Information
• Device Expiration Date: 09/11/2022
• Device Catalogue Number: 60P055
• Device Lot Number: 3502385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2018
• Supplement Date Received by Manufacturer: 09/03/2018
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1