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

Model Number 0803-0009

Device Problem Break (1069)

Patient Problem Aspiration/Inhalation (1725)

Event Date 03/27/2021

Event Type  malfunction  

Manufacturer Narrative

Since neither the customer nor the device information were provided on the initial manufacturer and user facility report, a device analysis could not be completed for the specified device.Should additional relevant information become available, a supplemental report will be submitted in accordance with 21 cfr 803.56.Corrective action is not required at this time.Verathon will continue to monitor for trends.

Event Description

This issue was reported via manufacturer and user facility report number (b)(4) which stated that during a patient procedure, using a gliderite rigid stylet, the blue handle / thumb tab of the rigid stylet broke off.The customer was unable to retrieve the metal portion of stylet from the endotracheal tube.The endotracheal tube had to be removed and the patient re-intubated.No use of a backup device, or harm to the user was reported.

• Brand Name: GLIDERITE RIGID STYLET
• Type of Device: STYLET, TRACHEAL TUBE
• Manufacturer (Section D): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C 5 A9; CA V5C 5A9
• MDR Report Key: 12046347
• MDR Text Key: 261963740
• Report Number: 9615393-2021-00201
• Device Sequence Number: 1
• Product Code: BSR
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0803-0009
• Device Catalogue Number: 0270-0681
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1