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

Catalog Number	0P055
Medical Device Problem Codes	Material Discolored (1170); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation results: one used bivona tracheostomy tube was returned for investigation without its original packaging inside a (b)(4) 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.
Event or Problem Description
It was reported that the lower shaft of the cannula was discolored and rough after two weeks of use.No reprocessing measures were taken.No patient injury or complications were reported in relation to this event.

• Brand Name: BIVONA
• 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: 8923203
• Report Number: 3012307300-2019-04222
• Device Sequence Number: 14027183
• Product Code: BTO
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/22/2019

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 Expiration Date: 09/11/2022
• Device Catalogue Number: 0P055
• 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
• Initial Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1