MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDERITE RIGID STYLET; STYLET, TRACHEAL TUBE

Model Number	0803-0009
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Codes	Unintended Extubation (4564); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer reported during a difficult intubation, using a gliderite rigid stylet, the lower part of the handle broke off when withdrawing the stylet from the endotracheal (et) tube.It was reported that the broken piece completely blocked the et tube lumen, requiring re-intubation of the patient.No piece of the stylet handle was reported to have fallen into the patient.No harm to the patient was reported.The date of incident was not reported.
Additional Manufacturer Narrative
The reported gliderite rigid stylet was not returned to verathon for evaluation, therefore the cause of the reported incident could not be determined.Review of photo evidence provided shows a portion of the separated stylet handle inside the lumen of a rusch 7.5 id oral-nasal et tube.No identifying information is visible from the photo of the stylet to confirm its lot number or date of manufacture.It is unknown how many reprocessing cycles the stylet underwent or if the handle was already damaged prior to the reported incident.Trending analysis for gliderite rigid stylets does not identify any trends exceeding acceptable limits.Verathon confirmed that the risk associated with the hazardous scenario has been adequately captured and characterized per the system risk assessment.Corrective action is not required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDERITE RIGID STYLET
• Common Device Name: STYLET, TRACHEAL TUBE
• Manufacturer (Section D): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C 5 A9; CA V5C 5A9
• Manufacturer (Section G): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C 5 A9; CA V5C 5A9
• Manufacturer Contact: corey kasbohm ; 20001 n creek pkwy; bothell, WA 98011-8218 ; 4256295760
• MDR Report Key: 24379877
• Report Number: 9615393-2026-00021
• Device Sequence Number: 16094006
• Product Code: BSR
• UDI-Device Identifier: 00879123006288
• UDI-Public: 00879123006288
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/18/2026

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: 0803-0009
• Device Catalogue Number: 0270-0681
• 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: 10/23/2024
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown