MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BIVONA CUSTOMIZATION SERVICES; 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	Serious Injury
Event or Problem Description
Information was received indicating that, while in use with a patient, this tracheostomy tube exhibited leaking issues.It was noted that the tube was not filling symmetrically.The tube was removed and replaced.No additional adverse patient effects were reported.

• Brand Name: PORTEX® BIVONA CUSTOMIZATION SERVICES
• 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: 7550355
• Report Number: 3012307300-2018-02003
• Device Sequence Number: 16573829
• 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): 05/29/2018

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: No Information
• Device Expiration Date: 04/02/2023
• 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: 05/03/2018
• Initial Report FDA Received Date: 05/29/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention