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	03/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer was unable to have the gliderite single-use stylet - small returned to verathon for evaluation as it had already been discarded.Since the device was not returned to verathon for evaluation, the cause could not be determined; however it is likely that bending the stylet for a very anterior position may have caused or contributed to it breaking.Trending analysis for the gliderite single-use 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 currently not required at this time.Verathon will continue to monitor for any ongoing trends.
Event or Problem Description
A customer reported while intubating a patient using a gliderite single-use stylet - small, the stylet broke inside a 3.5mm endotrachial (et) tube.It was reported that the intubation was difficult and the physician was manipulating the tube and attempting to bend the stylet for a very anterior position.The stylet was removed from the patient's airway in two pieces.It was confirmed that no part of the stylet was left in the patient and no harm to the patient was reported.

• 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 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: 21746692
• Report Number: 9615393-2025-00034
• Device Sequence Number: 11744567
• Product Code: BSR
• UDI-Device Identifier: 00879123005960
• UDI-Public: 00879123005960
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2025

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: 03/13/2025
• Initial Report FDA Received Date: 04/01/2025
• 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 Sex: Unknown