MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BIVONA® CUSTOM 6.5 A/C STANDARD NS TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	CM3162N
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is currently being evaluated; smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.Device evaluation in progress.
Event or Problem Description
It was reported that the balloon of a portex® bivona® custom 6.5 a/c standard ns tracheostomy tube was leaking after one week in use.The leak was noticed by a private duty nurse during bedside care.Cuff patency was tested prior to use, and the cuff was filled with air.Velcro tracheostomy tube ties were used to hold the device in place.The nurse changed the tracheostomy tube.No injury was reported, and the event was reported as resolved.
Additional Manufacturer Narrative
One device was returned for evaluation.Functional testing involved leak testing and found no signs of leaking.A review of the device history record found that the lot had no abnormalities and was within specified dimensions.Functional testing involved dimensional testing and found the cuff passed the wall thickness specification.Based on the evidence, a root cause was unable to be confirmed.No fault was found with the device.

• Brand Name: PORTEX® BIVONA® CUSTOM 6.5 A/C STANDARD NS 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: 6541807
• Report Number: 3012307300-2017-00998
• Device Sequence Number: 340153
• Product Code: JOH
• UDI-Device Identifier: 15019517038866
• UDI-Public: 15019517038866
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,health p
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2017

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: Nurse
• Device Expiration Date: 08/10/2021
• Device Catalogue Number: CM3162N
• Device Lot Number: GS027458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2017
• Supplement Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 05/03/2017
• Supplement Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Weight: 38