MAUDE Adverse Event Report: CARDINAL HEALTH, INC. MONOJECT; CANNULA, SURGICAL, GENERAL PLASTIC SURGERY

Model Number	8881540111
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Cap that come with plastic needle does not latch on properly and not secured.

• Brand Name: MONOJECT
• Common Device Name: CANNULA, SURGICAL, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 17396476
• Report Number: 17396476
• Device Sequence Number: 20316103
• Product Code: GEA
• UDI-Device Identifier: 30884521102754
• UDI-Public: (01)30884521102754
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/09/2023
• Report Date (Section F): 05/09/2023

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
• Operator of Device: Health Professional
• Device Model Number: 8881540111
• Device Catalogue Number: 8881540111
• Device Lot Number: 208734
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/26/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2023
• 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: 05/09/2023