MAUDE Adverse Event Report: BOUND TREE MEDICAL, LLC CURAPLEX; OROTRACHEAL INTUBATION GUIDE KIT

Model Number 301-LED-101M

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

Event Date 09/25/2023

Event Type  malfunction  

Event Description

Great catch by pedi pa who was randomly looking at laryngoscopes while teaching/showing staff and noticed the miller 1 package contained a smaller blade, it was actually a 0.Curaview led laryngoscope hand and blade, miller size 1 package, contained a size 0 blade.These are one time use, prepackaged neonatal scopes and blades.Sticker on packaging read: mini miller blade size item 301-led-101m batch code 190424f.

• Brand Name: CURAPLEX
• Type of Device: OROTRACHEAL INTUBATION GUIDE KIT
• Manufacturer (Section D): BOUND TREE MEDICAL, LLC; 5000 tuttle crossing blvd; dublin OH 43016
• MDR Report Key: 18182260
• MDR Text Key: 328674037
• Report Number: 18182260
• Device Sequence Number: 1
• Product Code: OGK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 301-LED-101M
• Device Catalogue Number: 301-LED-101M
• Device Lot Number: 190424F
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/26/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/21/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female