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 Unintended Extubation (4564)

Event Date 09/13/2022

Event Type  malfunction  

Event Description

The following was reported by a user facility via medsun mandatory and voluntary report number (b)(4) which stated that during an emergency care procedure of a 9-month old patient, using a gliderite single-use stylet - small, the stylet snapped prompting a repeat intubation attempt with a different tube and stylet.The patient was bagged between intubation attempts with no difficulty, was successfully intubated, and transferred to the pediatric intensive care unit (picu).No harm to the patient was reported.

Manufacturer Narrative

The initial reported device used during the patient procedure was not retained by the facility and therefore will not be returning to verathon for evaluation.However, the facility plans on returning additional samples from their stock for evaluation.Initial follow-up information received from the facility reported that the stylet broke at the bended section while trying to adjust it during intubation.The broken piece was retrieved but they did not indicate from where.Verathon continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Manufacturer Narrative

Replacement gliderite single-use stylets - small were provided to the customer and eight (8) unopened stylets from the same lot of the reported stylet were returned to verathon.The device used during the reported event was not retained by the facility and therefore was not able to be returned to verathon for evaluation.Since the reported device was not returned to verathon for evaluation, the cause could not be determined.However, based on follow-up information received from the facility, it is likely that the cause of the reported event may have been due to the stylet being bent while trying to adjust it during intubation.The gliderite single-use stylets are not to be bent or reshaped, as the shape of the stylet is designed to complement the curve of glidescope video laryngoscopes.The model and size of the et tube used with the stylet during the reported event is unknown.The gliderite single-use stylet (small) instructions for use states: "the stylet is for use in et tubes between 3.0 and 4.0 mm in internal diameter.Note: there is no guarantee that instruments selected solely using these intrument deminsions will be compatible in combination." review of complaint history for the reported gliderite single-use stylet - small, lot number "gs77314," identified one (1) other complaint reported to verathon in august 2021.Trending analysis for the gliderite single-use stylet - small 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 trends.

• 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: 15798141
• MDR Text Key: 303752917
• Report Number: 9615393-2022-00209
• Device Sequence Number: 1
• Product Code: BSR
• UDI-Device Identifier: 10879123005967
• UDI-Public: 011087912300596710GS7731417240331
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 0803-0118
• Device Catalogue Number: 0270-0916
• Device Lot Number: GS77314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 9 MO
• Patient Sex: Female
• Patient Weight: 6 KG
• Patient Race: White