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 07/26/2023

Event Type  malfunction  

Event Description

Curaplex curaview led laryngoscope handle and blade size 1 was noted to have a small (approximately 1 cm) dark blue plastic piece in the package.Upon opening the package, it looks as though the piece was broken off the handle of the product.Product was not used and was sequestered.Of note: this laryngoscope handle and blade is not the typical product we use.

• 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: 18182212
• MDR Text Key: 328673324
• Report Number: 18182212
• 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 Model Number: 301-LED-101M
• Device Catalogue Number: 301-LED-101M
• Device Lot Number: 109424F0324
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1