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

Model Number 0803-0118

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2023

Event Type  malfunction  

Manufacturer Narrative

The customer was unable to have their 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.Upon following up with the customer, they reported that the stylet was not manipulated during insertion or removal from the et tube.The customer also provided a photo of the broken stylet piece stuck inside the et tube which showed the curved portion of the stylet facing the opposite orientation of the curved portion of the et tube.While the root cause could not be determined, it is possible that the stylet may have broke due to being misaligned during either its initial insertion or removal from the et tube, as photos indicate the curvature of the stylet that broke was inverted with the curved shape of the et tube.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.

Event Description

A customer reported that during a patient procedure, using a gliderite single-use stylet - small, the stylet broke inside the et tube that was in the patient.It was reported that the stylet broke while being removed from the sheridan et tube, size 5.0.No delay in the procedure, use of a backup device, or harm to the patient was reported.

• Brand Name: GLIDERITE SINGLE-USE STYLET - SMALL
• Type of Device: 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: 16410238
• MDR Text Key: 310243419
• Report Number: 9615393-2023-00041
• Device Sequence Number: 1
• Product Code: BSR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1