MAUDE Adverse Event Report: SMITHS MEDICAL, ASD, INC. PORTEX® BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	60P040
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The tracheostomy tube is for single patient use, but can be used multiple times on the same patient.(b)(6).
Event or Problem Description
It was reported that a customer replaced a portex® bivona® uncuffed pediatric tracheostomy tube with a new one.Two weeks later, a crack was found in the flange.No patient injury.
Additional Manufacturer Narrative
One portex® bivona® uncuffed pediatric tracheostomy tube was received for analysis.Visual inspection was performed at a distance of 12" to 24" under normal conditions of illumination.It was observed that the neck flange has a split.The manufacturing and quality inspection processes were reviewed and considered adequate and correct for testing and inspection activities.An attempt to produce the failure by making a small cut in a neck flange eyelet with a blade was performed in two pieces.It was possible to reproduce the failure.After review of the different verifications that are performed during the manufacturing process to detect damaged components, the most probable root cause is that damage occurred after the product left the smiths healthcare facility.

• Brand Name: PORTEX® BIVONA® UNCUFFED NEONATAL AND PEDIATRIC 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: 7383522
• Report Number: 3012307300-2018-00652
• Device Sequence Number: 16182438
• Product Code: JOH
• UDI-Device Identifier: 15021312005752
• UDI-Public: 15021312005752
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K912469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2018

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: Health Professional
• Device Catalogue Number: 60P040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2018
• Supplement Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 03/29/2018
• Supplement Report FDA Received Date: 06/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1