MAUDE Adverse Event Report: ROI CPS, LLC REGARD; NEURO PACK

Model Number NU00096AJ

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 03/13/2023

Event Type  malfunction  

Event Description

Damaged packs identified while setting up for case.Damage was to the vented bag.Damaged kits were removed and a new kit opened for case.No patient contact.

• Brand Name: REGARD
• Type of Device: NEURO PACK
• Manufacturer (Section D): ROI CPS, LLC; 3000 east sawyer road; republic MO 65738
• Manufacturer (Section G): ROI CPS, LLC; 3000 east sawyer road; republic MO 65738
• Manufacturer Contact: cheyenne stewart ; 3000 east sawyer road; republic, MO 65738 ; 4176473205
• MDR Report Key: 16727897
• MDR Text Key: 313166081
• Report Number: 3014527682-2023-00005
• Device Sequence Number: 1
• Product Code: OJG
• UDI-Device Identifier: 10194717114024
• UDI-Public: 10194717114024
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/12/2023

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: NU00096AJ
• Device Catalogue Number: 880096036
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2023
• Initial Date FDA Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: No
• 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