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

Model Number	670190
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cuff of the tracheostomy tube was found leaking after 12 hours of usage.No patient injury was reported.
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during this device history record review.Two photos were included for evaluation; the photos showed the complaint sample.A returned sample was received in use conditions without the original packaging.Visual inspection: the returned sample was visually inspected at 12in to 16in and normal conditions of illumination.Per visual inspection, damage was detected in the cuff of the tracheal tube.Leak test: the leak test was performed, the returned sample was inflated with a syringe and submerged under water to detect any leakage, the sample failed the test.The complaint was confirmed.Based on the analysis performed on the sample and the photos provided, the leakage failure mode was confirmed.However, according to the customer's report, the product was found damaged during use, during pre-testing no leakage was reported in the cuff as described in the instructions for use (ifu), and it was up to 12 hours after use that the leakage occurred in the product, the root cause could be due to improper use of the product.Also, capa was opened on january 5th, 2022, to address root cause investigation for leakage issues.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY TUBE
• 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: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13175645
• Report Number: 3012307300-2022-00206
• Device Sequence Number: 4857092
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2023

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: 02/23/2026
• Device Model Number: 670190
• Device Lot Number: 4092686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2021
• 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
• Patient Sex: Unknown