MAUDE Adverse Event Report: CARDINAL HEALTH MONOJECT; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	1188830340
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Needle became dislodged when secured to syringe.

• Brand Name: MONOJECT
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 18912147
• Report Number: 18912147
• Device Sequence Number: 6886545
• Product Code: FMI
• UDI-Device Identifier: 10884521007475
• UDI-Public: 10884521007475
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/16/2023
• Report Date (Section F): 11/16/2023

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: 1188830340
• Device Catalogue Number: 1188830340
• Device Lot Number: 23D013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/15/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/15/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/16/2023