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

Model Number	XT20BS35NGF855N
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation and upon an initial visual inspection of the trach it was noted that the valve was not properly placed inside the balloon.While the investigation notes that this was affecting the inflation and deflation of the cuff by slowing it, it was also noted that during decontamination, the interior areas of the tube were cleansed, and the valve was manually manipulated which may have altered its position from how the customer had originally sent it (this has since been discussed with the decontamination facility and has been addressed to avoid this issue in the future).Once the valve was reinserted into the balloon to its correct position there was significantly quicker inflation and deflation.It is possible that the decontamination process affected this product.However, the cause of the complaint, the cuff was not inflating, could not be determined.During production, all cuffed products are leak-tested at two separate points, including one inspection at the very end of the manufacturing process, both checks would likely have discovered any issues related to inflation and deflation of the cuff (including any issue with the valve being placed incorrectly) during these check points before it shipped to the customer.Root cause could not be defined with confidence.Product is accepted based on meeting specification requirements.Inspections and tests are conducted by trained operators through 100 percent screening inspection before shipment.A device history record (dhr) review indicated that a rework may be related (replace neck flange).One of the two trachs from this lot were reworked during the assembly process.It is unclear which piece had this replacement done, however, it is possible that rework done on this part of the product could affect the airflow to the cuff and prevent proper inflation.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that the cuff was not inflating.No patient injury was reported.

• Brand Name: BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15464361
• Report Number: 3012307300-2022-20088
• Device Sequence Number: 17858544
• Product Code: JOH
• UDI-Device Identifier: 15019517221954
• UDI-Public: 15019517221954
• 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): 09/21/2022

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: 03/02/2025
• Device Model Number: XT20BS35NGF855N
• Device Catalogue Number: XT20BS35NGF855N
• Device Lot Number: SS027324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2022
• Initial Report FDA Received Date: 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2020
• 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