MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BIVONA ¿ TTS¿ NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	60P055
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that a smiths medical tracheostomy was noted to have fungus like substance in the tube.The tracheostomy tube was changed out, and no patient adverse effects resulted.
Additional Manufacturer Narrative
Evaluation results: one bivona tracheostomy tube (neo/ped) was received without the original packaging inside a ziploc bag.The device was received in used condition.Visual inspection was performed at 12 inches under normal conditions of illumination in order to detect any contamination on the unit.It was observed that the sample was contaminated with small yellow spots.The substance was transferred to 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 likely that the unit was contaminated after it left the manufacturing facility.

• Brand Name: PORTEX® BIVONA ¿ TTS¿ NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8446378
• Report Number: 3012307300-2019-01452
• Device Sequence Number: 2051410
• Product Code: BTO
• UDI-Device Identifier: 15021312005783
• UDI-Public: 15021312005783
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/31/2019

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: No Information
• Device Catalogue Number: 60P055
• Device Lot Number: 3672616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 05/03/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 05/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention