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

Model Number	0803-0118
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
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.Follow-up information received from the customer reported that the et tube used with the stylet during the reported incident was an avanos microcuff 3.0mm et tube.A photo was provided of a representative, unused stylet showing the location of the breakage which indicated to be above the curved distal portion.The customer reported that the stylet was angled appropriately during its removal from the et tube.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 snapped while trying to remove it from a 3mm endotrachial (et) tube.It was reported that a portion of the broken stylet remained inside the et tube but users were able to successfully remove the broken piece without needing to replace the et tube.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: 20375657
• Report Number: 9615393-2024-00125
• Device Sequence Number: 3688874
• Product Code: BSR
• UDI-Device Identifier: 00879123005960
• UDI-Public: (01)00879123005960(10)GS79355(11)211207(17)241207
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/06/2024

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 Expiration Date: 12/07/2024
• Device Model Number: 0803-0118
• Device Catalogue Number: 0270-0916
• Device Lot Number: GS79355
• 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: 09/06/2024
• Initial Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2021
• 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