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

Model Number 67SP025

Device Problem Leak/Splash (1354)

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/21/2021

Event Type  Injury  

Event 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
• Type of Device: 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: 12808237
• MDR Text Key: 280739989
• Report Number: 3012307300-2021-11181
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15021312000665
• UDI-Public: 15021312000665
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K914088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 10/22/2021
• Initial Date FDA Received: 11/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1