MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA UNCUFFED NEONATAL FLEXTEND PLUS STRAIGHT FLANGE TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	60NFPS35
Medical Device Problem Codes	Break (1069); Fracture (1260); Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that the flange of a smiths medical bivona uncuffed neonatal flextend plus straight flange tracheostomy tube cracked and separated from the tube.There were no adverse effects.
Additional Manufacturer Narrative
Evaluation results: four (4) bivona tracheostomy tubes (neo/ped flextend plus) were received without their original packaging inside a ziploc bag.The samples were received in used condition.Visual inspection was performed at 12 inches under normal conditions of illumination in order to detect any damage on the parts.During the visual inspection, it was observed that the flanges were broken and had splits.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.The most probable root cause is that the damage occurred after the product left the manufacturing facility.

• Brand Name: BIVONA UNCUFFED NEONATAL FLEXTEND PLUS STRAIGHT FLANGE TRACHEOSTOMY TUBE
• 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: 8647831
• Report Number: 3012307300-2019-01750
• Device Sequence Number: 2353871
• Product Code: JOH
• UDI-Device Identifier: 15021312516692
• UDI-Public: 15021312516692
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2019

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?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 60NFPS35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 05/28/2019
• Supplement Report FDA Received Date: 05/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1