MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	FT17BN55NSF101S
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that the cuff to a smiths medical portex bivona flextend¿ tts¿ tracheostomy tube inflated unevenly.There were no reported adverse patient effects.
Additional Manufacturer Narrative
One flextend¿ tts¿ tracheostomy tube was returned for analysis.No defects were observed upon visual examination.Inflation test was performed by inserting air into the cuff per inflation line.The device was then measured noting the following: smaller side of cuff read 10mm and larger side of cuff measured 11mm.Four thickness measurements of the cuff were taken by removing the cuff from the shaft; all measurements were within specification.Based on the evidence, the cuff may have appeared to be inflated unevenly but the investigation was determined to meet the manufacturing specification; thus no root cause was found.

• Brand Name: PORTEX BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBES
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 8020610
• Report Number: 3012307300-2018-01937
• Device Sequence Number: 1640814
• Product Code: JOH
• UDI-Device Identifier: 15019517097252
• UDI-Public: 15019517097252
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2018

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: 11/30/2022
• Device Catalogue Number: FT17BN55NSF101S
• Device Lot Number: DS010950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 12/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1