MAUDE Adverse Event Report: 3M COMPANY CUROS; PAD, ALCOHOL, DEVICE DISINFECTANT

Model Number	CM5-200
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Multiple curos tips have been unable to be placed due to being filled with hard plastic.One cap has been retrieved, but no packaging was saved with it.

• Brand Name: CUROS
• Common Device Name: PAD, ALCOHOL, DEVICE DISINFECTANT
• Manufacturer (Section D): 3M COMPANY; 3m center, 2510 conway ave.; bldg. 275-5w-06; saint paul MN 55144
• MDR Report Key: 20902111
• Report Number: 20902111
• Device Sequence Number: 9052843
• Product Code: LKB
• UDI-Device Identifier: 00707387773793
• UDI-Public: (01)00707387773793
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/05/2024
• Report Date (Section F): 12/05/2024

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: CM5-200
• Device Catalogue Number: CM5-200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2024
• 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: 12/05/2024