MAUDE Adverse Event Report: FLEXICARE INC BRITEPRO SOLO MINI SINGLE-USE FIBER OPTIC LARYNGOSCOPE HANDLE, MILLER; LARYNGOSCOPE, RIGID

Model Number 040-310U , 040-309U

Device Problems Display or Visual Feedback Problem (1184); Structural Problem (2506); Difficult or Delayed Activation (2577); Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Unspecified Respiratory Problem (4464)

Event Date 10/01/2022

Event Type  malfunction  

Event Description

Infant patient had been inpatient since birth, when born with left ventricle hypoplastic heart syndrome, paresis of left vocal cord, aortic stenosis.Medical complexity known while in utero.Patient was being intubated for clinical decompensation and at high risk for cardiac arrest.The patient was intubated using the miller disposable laryngoscope.The plastic material reduces maneuverability of the mucosa and tissues in the oropharynx causing the tissues and epiglottis to slip off the blade easily.The led light and blue color of the plastic blade give a blue/purple hue inside the oropharynx, making it difficult to quickly identify anatomical landmarks for good visualization.These complications led to a delay in establishing a timely airway for this patient, who progressed to cardiac arrest and required ecpr.This product was discarded.

• Brand Name: BRITEPRO SOLO MINI SINGLE-USE FIBER OPTIC LARYNGOSCOPE HANDLE, MILLER
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): FLEXICARE INC; 15281 barranca pkwy, unit d; irvine CA 92618
• MDR Report Key: 15751582
• MDR Text Key: 303259477
• Report Number: 15751582
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 040-310U , 040-309U
• Device Catalogue Number: 040-309U, 040-03-000U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/24/2022
• Event Location: Other
• Date Report to Manufacturer: 11/08/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 150 DA
• Patient Sex: Male
• Patient Weight: 5 KG