MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA; TRACHEOSTOMY

Model Number	65P030
Medical Device Problem Codes	Fumes or Vapors (2529); Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical tracheostomy|silicone - bivona tubes neo/ped aire-cuf has oil pollution on inner boxes.Photos attached.No adverse patient events reported.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 12221006
• Report Number: 3012307300-2021-07595
• Device Sequence Number: 16491530
• Product Code: JOH
• UDI-Device Identifier: 15021312005950
• UDI-Public: 15021312005950
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/23/2021

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 Expiration Date: 12/16/2024
• Device Model Number: 65P030
• Device Catalogue Number: 65P030
• Device Lot Number: 3923718
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1