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

Model Number	FT14HN35NGE266S
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr was generated under protocol b10009704, as a result of warning letter cms# (b)(4).A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection indicated that two devices showed signs of wear.One of the two that showed signs of wear had a cut in the inflation balloon.The third trach did not show signs of wear.A visual inspection of the two devices without a cut to the balloon showed teflon spray inside one of the cuffs.Teflon spray is inserted under the cuff to prevent sticking of the cuff to the shaft.No hard pieces were detected in the cuffs.An inspection of the trach with the cut in the balloon revealed that the teflon tubing, which attaches the airway line to the shaft, had migrated to the balloon.Further inspection of the other two used devices confirmed the teflon tubing had been dislodged from the shaft.The teflon tubes were determined to be the correct size for devices.The root cause of the reported issue was unable to be determined.The investigation could not confirm whether the teflon tube was not initially installed fully, whether manipulation of the airway line or whether the force of the water caused the teflon tube to move from its position.
Event or Problem Description
It was reported that hard piece of plastic was floating in the pilot balloon.No patient injury was reported.

• Brand Name: TRACHEOSTOMY SILICONE - 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: 15607364
• Report Number: 3012307300-2022-24075
• Device Sequence Number: 19402643
• Product Code: JOH
• UDI-Device Identifier: 10351688740182
• UDI-Public: 10351688740182
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2022

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: 10/18/2024
• Device Model Number: FT14HN35NGE266S
• Device Catalogue Number: FT14HN35NGE266S
• Device Lot Number: DS032263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2019
• 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