MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL SILICONE BIVONA TUBES NEO/PED; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	67NFPS30
Medical Device Problem Codes	Malposition of Device (2616); Output Problem (3005)
Health Effect - Clinical Codes	Respiratory Distress (2045); No Information (3190)
Date of Event	10/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that while a smiths medical tracheostomy has a cannula and flange that are movable.The obturator needs to be inserted in order to place the tracheostomy tube.The flange does not have directional orientation to it.No adverse effects have been reported.
Additional Manufacturer Narrative
Additional information was received indicating that the patient had been experiencing stridorous breath sounds.It had been discovered that the trach tube had been inserted upside down.The medical team and respiratory therapist were notified.The trach tube was then changed out.It was reported that the flange numbers are observed to be small and hard to see.

• Brand Name: SMITHS MEDICAL SILICONE BIVONA TUBES NEO/PED
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis MN 55442
• MDR Report Key: 9336966
• Report Number: 3012307300-2019-06279
• Device Sequence Number: 11244615
• 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: K923878
• 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,Followup
• Report Date (Section B): 01/14/2020

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 Catalogue Number: 67NFPS30
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 01/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 9 MO
• Patient Weight: 3