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

Model Number	ST17HN50NSC035N
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were no non-conforming reports (ncrs) initiated for the lot or anomalies identified in the device history record (dhr) review.One sample returned in used condition and without its original packaging.Visual inspection revealed contamination under the distal cuff and contamination surrounding the portion of the inflation valve that extends outside the balloon.The cuff was removed from the shaft and the contamination was inspected using magnification.The contamination inside the cuff was flat and had various fibers.The contamination surrounding the inflation valve had similar fibers that were seen in the contamination inside the cuff as well as red dots that appeared to resemble glitter.A substance that appeared oily was observed on the portion of the valve that was inserted into the balloon.The root cause was unable to be determined the investigation could not identify the source of the contamination.No corrective actions are planned at this time.The manufacturer regularly analyzes complaint data and trends and will take further actions accordingly.This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that there were particles in the cuff of the device.No patient injury was reported.

• Brand Name: BIVONA TUBES CUSTOM
• 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: 15668506
• Report Number: 3012307300-2022-26167
• Device Sequence Number: 6348784
• Product Code: JOH
• UDI-Device Identifier: 15019517118414
• UDI-Public: 15019517118414
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/25/2022

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: 02/08/2024
• Device Model Number: ST17HN50NSC035N
• Device Catalogue Number: ST17HN50NSC035N
• Device Lot Number: DS024176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2019
• 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