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

Catalog Number	ST17BN40NSB063N
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Distributor reported that the cuff of a tracheostomy tube being used with a ventilator-dependent patient experienced a leak and had low volumes.Cuff patency was not tested prior to use, and sterile water had been used to fill the cuff.Although no injury was associated with this incident, a trach tube changeout was required.
Additional Manufacturer Narrative
One customized 4.0 tts tracheostomy tube was returned.A visual inspection of the device revealed no defects.Using leak test using 10cc of air was applied to the device and no leaks were detected.The cuff was filled with 10cc of water and allowed to sit for a couple of hours with no signs of leaking.The cuff symmetry was acceptable.The investigation was unable to detect any defects with the returned device.

• Brand Name: PORTEX® BIVONA® TTS 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: 7716041
• Report Number: 3012307300-2018-02817
• Device Sequence Number: 13733245
• Product Code: JOH
• UDI-Device Identifier: 15019517106824
• UDI-Public: 15019517106824
• 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: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/11/2023
• Device Catalogue Number: ST17BN40NSB063N
• Device Lot Number: DS016222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2018
• Supplement Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 09/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 5 YR