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

Model Number	670190
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the cuff was functioning normally during the pre-test, but the ventilator alarmed after the tube was placed.Three days later, the cuff was found leaking.No polyp was found through bronchoscopy examination.A trach change was done to resolve the issue.No patient harm reported.
Additional Manufacturer Narrative
Other, other text: this mdr was generated under protocol b10010116, as a result of warning letter cms# 617147.Additional information h6, h10 no problems or issues were identified during this device history record review.Visual and functional tests were performed.Two images were received along with one (1) sample received in used conditions, without its original packaging.The sample was tested on leak test.The test was performed under water.During the test, a leak was found in the cuff.The complaint was confirmed.Then the cuff was filled with water, a leak was found at the middle section of cuff.The cuff was inspected, to observe better the shape of the pinhole found during leak test.The hole was observed with a circular shape with flash in the periphery.Based on the tests performed to replicate the failure mode, where it could not be reproduced using the tools from assembly process, the most probable root cause is that damage occurred after the product left the manufacturing facility.The root cause could not be determined.No corrective actions were taken since the investigation did not reveal that the defect was caused during the manufacturing process.

• Brand Name: SILICONE - BIVONA TUBES ADULT TTS
• Common Device Name: TRACHEOSTOMY TUBE AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12418151
• Report Number: 3012307300-2021-09120
• Device Sequence Number: 6290451
• Product Code: JOH
• UDI-Device Identifier: 15021312006094
• UDI-Public: 15021312006094
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: 670190
• Device Catalogue Number: 670190
• Device Lot Number: 3989652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/04/2021
• Supplement Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown