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

Model Number	HT14KS60NSC287S
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was fuzz visible in cuff.No patient injury was reported.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspection were completed and no issues were noted during manufacture.Two 6.0mm id customized fixed hyperflex tracheostomy tubes with adult flanges, swivel connectors and tts cuffs were returned for fuzz/contamination inside the cuff and the cuff not inflating properly.Both device cuffs were inflated using air in according to wi-10-012.Upon visual inspection, no fuzz was present in either cuff or inflation balloon.Both cuffs had teflon spray visible through the cuff.When the device is manufactured, the tts cuff is sprayed internally with a liquid teflon spray (ptfe release agent) to coat the inside of the cuff to prevent the silicone cuff from sticking to the shaft.Teflon spray appears foggy when looking through the clear cuff and allows it to inflate and deflate properly.Both cuffs inflated and deflated accordingly with no difficulties observed.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.

• Brand Name: BIVONA
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15476361
• Report Number: 3012307300-2022-20197
• Device Sequence Number: 6071033
• Product Code: JOH
• UDI-Device Identifier: 15019517022605
• UDI-Public: 15019517022605
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2022

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: Health Professional
• Device Expiration Date: 05/24/2024
• Device Model Number: HT14KS60NSC287S
• Device Lot Number: DS027140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2022
• Initial Report FDA Received Date: 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown