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

Catalog Number	HT16BS45NSB017S
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
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 excessive powder like material was noted within a cuff to a smiths medical portex bivona flextend¿ tts¿ tracheostomy tube.Black and red specks of material were also noted on the tracheostomy (trach) tube; which appeared to be dusty and dirty.The trach was not used on the patient.There were no reported adverse effects.
Additional Manufacturer Narrative
Two customized hyperflex tracheostomy tubes with tts cuffs were returned for analysis.Under visual examination one cuff appeared to have a significant amount of teflon (i.E., white-colored powder) inside the cuff.The other cuff did not appear to have a significant amount of teflon visible with no visible black or red specks of material on the devices.Review of teflon dispensing (i.E., dispensing pressure, dispensing time, and magnetic stirrer dial setting) were recorded in the dhr and determined to be per the manufacturing requirements.The cuff was inflated with water which dissolved the deposited teflon.It is possible that the operator did not disperse the coating over the entire cuff and that a heavier accumulation of the teflon on one side appeared to be more visible.Based on the evidence the complaint was confirmed but no fault 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: 7759089
• Report Number: 3012307300-2018-03050
• Device Sequence Number: 16463755
• Product Code: JOH
• UDI-Device Identifier: 15019517040098
• UDI-Public: 15019517040098
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/28/2018

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: 11/27/2022
• Device Catalogue Number: HT16BS45NSB017S
• Device Lot Number: DS010543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 08/31/2018
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1