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

Model Number 0803-0118

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Bradycardia (1751); Low Oxygen Saturation (2477)

Event Date 05/02/2022

Event Type  malfunction  

Event Description

The customer reported that during a patient procedure, using a gliderite single-use stylet - small, the stylet fragemented into several pieces while being inserted into the endotracheal tube (et).It was reported that the intubation was delayed due to the stylet breaking which resulted in the patient experiencing decreased oxygen saturation and bradycardia until they recovered with ambu-bagging.

Manufacturer Narrative

The customer declined the option to have their glidescope single-use stylet - small returned to verathon for evaluation.Since the device was not returned to verathon for evaluation, the cause could not be determined.Upon following up with the customer, they reported using an et tube with internal diameter size 3.5 mm but the manufacturer and model is unknown.They reported the physician involved in the patient's care did not bend or straighten the stylet in any way prior to use or do anything different than their normal practice.The customer declined to provide any information regarding the 1 year-old patient's medical condition and why they were being intubated.Verathon continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 if additional information becomes available.

• Brand Name: GLIDERITE SINGLE-USE STYLET - SMALL
• Type of Device: LARYNGOSCOPE, RIGID
• 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: 14548468
• MDR Text Key: 299395726
• Report Number: 9615393-2022-00098
• Device Sequence Number: 1
• Product Code: CCW
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2022
• Device Model Number: 0803-0118
• Device Catalogue Number: 0270-0916
• Device Lot Number: GS58191
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2019
• 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
• Patient Age: 1 YR