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

Catalog Number	FT18DN40NGF999N
Medical Device Problem Codes	Air Leak (1008); Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cuff of the tracheostomy tube was not inflating properly, and the air was leaking.The same tube was tried twice on the same patient.No injury was reported.

• Brand Name: PORTEX® BIVONA® 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: 7481193
• Report Number: 3012307300-2018-01261
• Device Sequence Number: 1340004
• Product Code: JOH
• UDI-Device Identifier: 15019517146028
• UDI-Public: 15019517146028
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/02/2018

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: No Information
• Device Expiration Date: 03/02/2023
• Device Catalogue Number: FT18DN40NGF999N
• Device Lot Number: SS014118
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2018
• Initial Report FDA Received Date: 05/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1