MAUDE Adverse Event Report: FLEXICARE MEDICAL LTD BRITEPRO SOLO; LAYRYNOSCOPE

Catalog Number 040-310U

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Activation Problem (4042)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2023

Event Type  malfunction  

Event Description

The event as reported to the manufacturer.'the code related event occured in one code where three striaght handles were attempted to be used for an intubation but were all found to have non-functining light sources.Because the lights di dnot function, they di dnot make any contact with the patinet.A reusable handle was located and that was used to safely intubate the patient though the customer did state that care was delayed due to the product event.'.

• Brand Name: BRITEPRO SOLO
• Type of Device: LAYRYNOSCOPE
• Manufacturer (Section D): FLEXICARE MEDICAL LTD; cwm cynon business park; mountain ash, rct CF45 4ER; UK CF45 4ER
• Manufacturer (Section G): FLEXICARE MEDICAL LTD (CHINA); no.b-15; xicheng industrial zone; dongguan, guangdong 52346 5; CH 523465
• Manufacturer Contact: julie davies ; cwm cynon business park; mountain ash, rct CF45 -4ER ; UK CF45 4ER
• MDR Report Key: 17572263
• MDR Text Key: 321423834
• Report Number: 3006061749-2023-00016
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 040-310U
• Device Lot Number: 190600159
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2019
• 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