MAUDE Adverse Event Report: FLEXICARE MEDICAL LTD. BRITEPRO OMNI SINGLE-USE LARYNGOSCOPE MINI HANDLE WITH MILLER 00; LARYNGOSCOPE, RIGID

Model Number	040-06-0400U
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Attended delivery of 24 week small for gestational age (sga) infant, weighing 470 grams.Intubation with flexicare britepro omni was very difficult.3 attempts before success.Infant was unstable and multiple intubation attempts could have been detrimental to infant's survival.Manufacturer response for laryngoscope, rigid, britepro omni single-use laryngoscope mini handle with miller 00 (per site reporter).They suggest we provide additional training.

• Brand Name: BRITEPRO OMNI SINGLE-USE LARYNGOSCOPE MINI HANDLE WITH MILLER 00
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): FLEXICARE MEDICAL LTD.; 15281 barranca pkwy, unit d; irvine CA 92618
• MDR Report Key: 20863537
• Report Number: 20863537
• Device Sequence Number: 8785901
• Product Code: CCW
• UDI-Device Identifier: 05055788773320
• UDI-Public: (01)05055788773320
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2024
• Report Date (Section F): 09/30/2024

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
• Operator of Device: Health Professional
• Device Model Number: 040-06-0400U
• Device Catalogue Number: 040-06-0400U
• Device Lot Number: 240200080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/06/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/30/2024