MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDERITE SINGLE-USE STYLET - SMALL; STYLET, TRACHEAL TUBE

Model Number	0803-0118
Medical Device Problem Codes	Material Separation (1562); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer was unable to return the gliderite single-use stylet - small to verathon for evaluation, as the device had already been discarded at the facility.Because the device was not available for evaluation, the cause of the reported failure could not be determined; however, previous investigations have indicated that bending or reshaping the stylet may cause or contribute to stylet breakage.The customer reported the stylet was properly arced toward the patient's feet upon removal from the et tube.Since no lot information was provided, search for complaint history of the subject device lot was unable to be performed.Trending analysis for the gliderite single-use stylets does not identify any trends exceeding acceptable limits.Verathon has confirmed that the risk associated with this hazardous scenario is adequately captured and characterized in the system risk assessment.Corrective action is not required at this time.Verathon will continue to monitor for any ongoing trends.
Event or Problem Description
A customer reported while emergently intubating a two-month-old patient, using a gliderite single-use stylet - small, the stylet broke in half during the attempted removal from the 3.5 mm endotrachial (et) tube after the patient was intubated.The et tube was removed and the patient was re-intubated.The incident caused a few minutes delay in patient care; however, no harm to the patient was reported.The customer confirmed that no broken pieces of the stylet fell into the patient.

• Brand Name: GLIDERITE SINGLE-USE STYLET - SMALL
• Common Device Name: STYLET, TRACHEAL TUBE
• Manufacturer (Section D): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C5A 9; CA V5C5A9
• Manufacturer (Section G): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C5A 9; CA V5C5A9
• Manufacturer Contact: corey kasbohm ; 20001 n creek pkwy; bothell, WA 98011-8218 ; 4256295760
• MDR Report Key: 24306223
• Report Number: 9615393-2026-00015
• Device Sequence Number: 12065903
• Product Code: BSR
• UDI-Device Identifier: 00879123005960
• UDI-Public: 00879123005960
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0803-0118
• Device Catalogue Number: 0270-0916
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 2 MO
• Patient Sex: Unknown