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

Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while replacing a tracheostomy tube (trach), via a blind placement, on small child in a turtle shell body cast, the operator inadvertently inserted the obturator and placed the trach upside down (in a flipped position).This resulted in the child experiencing respiratory distress, likely from the distal curvature of the trach.The operator subsequently removed the trach tube and reinserted it correctly.No patient injury or further complications were reported in relation to this event.

• Brand Name: BIVONA
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9239912
• Report Number: 3012307300-2019-05770
• Device Sequence Number: 16675708
• Product Code: JOH
• UDI-Device Identifier: 10351688518781
• UDI-Public: 10351688518781
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: 103516885187
• 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): 10/25/2019

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?: No
• Operator of Device: No Information
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1