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

Catalog Number	CM3345N
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One portex® bivona® custom 4.0mm tight to shaft with tracheostomy tube with murphy eye was returned for investigation.A manufacturing review was performed, and no non-conformities were found.Visual and functional examinations confirmed that the product has a leak where the airway line is secured to the tube.The airway line had been pulled away from the shaft.The airway line is designed to withstand 1lbf.Visual inspection confirmed there was presence of adhesive at the attachment site.A leak test on this product was performed prior to shipping.The evidence provided indicates the defect was not the result of a manufacturing defect.The root cause of the failure was found to be a user interface issue.The complaint was confirmed.
Event or Problem Description
It was reported that the cuff of a portex® bivona® custom tracheostomy tube was found to be defective while in use.Cuff patency was tested prior to use with sterile water, and this was the initial use of the tracheostomy tube.No injury was reported.

• Brand Name: PORTEX® BIVONA® CUSTOM 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: 6729296
• Report Number: 3012307300-2017-01543
• Device Sequence Number: 10983449
• Product Code: JOH
• UDI-Device Identifier: 15019517093834
• UDI-Public: 15019517093834
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date (Section B): 07/20/2017

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 Expiration Date: 01/30/2022
• Device Catalogue Number: CM3345N
• Device Lot Number: DS002181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2017
• Initial Report FDA Received Date: 07/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 7 MO