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

Model Number	67SP025
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	10/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient started to desaturate during an emergency procedure.A trach had to be used but the trach was not inflating.Seen with two tracks.No further adverse patient effects were reported.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: david halverson ; 6000 nathan lane north; loading dock a; minneapolis, MN 55442
• MDR Report Key: 12808229
• Report Number: 3012307300-2021-11180
• Device Sequence Number: 14641814
• Product Code: JOH
• UDI-Device Identifier: 15021312000665
• UDI-Public: 15021312000665
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/13/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 67SP025
• Device Catalogue Number: 67SP025
• Device Lot Number: 3589066
• 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: 10/22/2021
• Initial Report FDA Received Date: 11/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown