MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BIVONA FLEXTEND¿ TTS¿ NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	60P055
Medical Device Problem Code	Optical Discoloration (2999)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that a smiths medical tracheostomy tube had five cannulas of the lower shaft discolored and rough after two weeks of use.No reprocessing measures had been taken.
Additional Manufacturer Narrative
Evaluation results: one used bivona tracheostomy tube was returned for investigation without its original packaging inside a ziploc bag.Visual inspection was performed at 12 inches under normal conditions of illumination to detect for any contamination on the unit.The investigator observed that the sample was contaminated with yellow spots.The substance was wiped away with a towel.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.Based on the information provided in the complaint description, it is most likely that the unit was contaminated once it left the manufacturing facility.
Additional Manufacturer Narrative
Five (5) samples were received from p/n 60p055 l/n 3502385, 3537952, 3396435 and 3567282.The samples were in used condition.During visual inspection it was observed that the sample was contaminated with yellow spots.Based on the information provided in the complaint description, the customer reported condition was confirmed.Problem source most likely that the unit was contaminated 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: PORTEX® BIVONA FLEXTEND¿ TTS¿ 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: 8209187
• Report Number: 3012307300-2019-00009
• Device Sequence Number: 13867277
• 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,Followup
• Report Date (Section B): 08/25/2019

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 Catalogue Number: 60P055
• Device Lot Number: 3502385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 02/01/2019; 02/01/2019
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 08/25/2019; 08/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1