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

Model Number	0803-0118
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	12/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported via medwatch report number (b)(4) that a pediatric patient was intubated in the emergency room for airway protection and prior to transport departure to another facility.After the endotracheal tube (ett) was secured by the physician, the cuff was inflated and the stylet was to be removed.During the stylet removal, the stylet broke inside the ett and they were unable to remove it on the first attempt.As the ett was occluded with the broken stylet, the patient was immediately bagged by respiratory.The patient's oxygen saturation (sats) returned to 100% before the doctor manually attempted to remove the rest of the broken stylet which was eventually successfully removed.Upon being notified about the incident by the facility, it was reported to verathon that the stylet broke off below the stopper in the ett upon removal.The physician used a hemostat to successfully remove the broken piece from the ett.No harm to the patient was reported.
Additional Manufacturer Narrative
The customer was unable to have the gliderite single-use stylet - small returned to verathon for evaluation as it was thrown away at their facility.Since the device was not returned to verathon for evaluation, the cause could not be determined.Verathon attempted to follow-up with the facility for additional information regarding the reported event and use of the device, including the model and size of the ett used with the stylet.To date, no response has been received.Trending analysis for the gliderite single-use stylets does not identify any trends exceeding acceptable limits.Review of the system risk assessment confirmed that the risk associated with the hazardous scenario has been adequately captured and characterized by verathon.Corrective action is currently not required at this time.Verathon will continue to monitor for any ongoing trends.

• 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: 18565020
• Report Number: 9615393-2024-00017
• Device Sequence Number: 20864145
• Product Code: BSR
• UDI-Device Identifier: 10879123005967
• UDI-Public: 011087912300596710GS8037517241208
• 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
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/04/2024

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: 12/08/2024
• Device Model Number: 0803-0118
• Device Catalogue Number: 0270-0916
• Device Lot Number: GS80375
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2021
• 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 Age: 1 YR
• Patient Sex: Male
• Patient Race: White