MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SILICONE TRACHEOSTOMY TUBES; DISP BIVONA TRACHEOSTOMY TUBES

Catalog Number	ST24JN80FTZ093N
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This file was originally incorrectly filed under registration number mrn 1824231-2025-00025-00.The date of that submission was 28-oct-2025.H6: codes were updated.One device was returned for investigation.Leak testing yielded a hole being found in device cuff.Custom tracheostomy devices are leak test twice prior to leaving the facility, therefore this defect must have occurred outside of icu medical oversight and in possession of the customer.The defect is observed but cannot be attributed to the manufacturing process.Visual and functional testing was performed.The probable cause of the reported problem unknown.
Event or Problem Description
It was reported that the nursing service noticed that water (10 ml), which is used to inflate the cuff, has leaked out of the cuff.Subsequently, the nursing service took a closer look at the cannula and saw that there is a small hole in the cuff, and therefore it is leaking.For the nursing service, was difficult to assess whether the patient has suffered any health impairment as a result of this incident, as the patient¿s current condition is generally rather worse due to infections.The advice to seek medical help was given to the nursing service.The user of the device when the event occurred was a healthcare professional.The place where the event occurred was at the patient's house.The nursing service has switched to a backup cannula and provided ventilatory insufficiency in als.The nursing service stated that it is difficult to assess, as the patient is currently in poor health due to infections.The client recommended to the nursing service to seek medical assistance if the patient's condition should worsen.The incident is resolved in the sense that a different cannula was placed for the patient.They also found a hole in the cuff.The patient has a multi-resistant germ.The patient is a female who is 45 years old and has the initials (b)(6) and was born on (b)(6) 1980.The patient's ethnicity is latin american and she is caucasian.There was patient involvement.

• Brand Name: SILICONE TRACHEOSTOMY TUBES
• Common Device Name: DISP BIVONA TRACHEOSTOMY TUBES
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 w 23rd ave; gary IN 46406
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24152361
• Report Number: 3012307300-2026-00481
• Device Sequence Number: 9335946
• Product Code: JOH
• UDI-Device Identifier: 10887709135007
• UDI-Public: (01)10887709135007(17)300205(10)GB032522
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 01/22/2026

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 Catalogue Number: ST24JN80FTZ093N
• Device Lot Number: GB032522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown