MAUDE Adverse Event Report: CARDINAL HEALTH MAGELLAN; SYRINGE, PISTON

Model Number	8881893010
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Registered nurse (rn) was drawing up lantus and went to recap the needle to take to the patient.The needle went through the cap and stuck the rn.The rn is unaware of any medication went into her.Rn immediately cleaned the area and threw out the needle.

• Brand Name: MAGELLAN
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 18902189
• Report Number: 18902189
• Device Sequence Number: 9255756
• Product Code: FMF
• UDI-Device Identifier: 10884521005952
• UDI-Public: (01)10884521005952
• 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: 8881893010
• Device Catalogue Number: 8881893010
• 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: Hospital
• Date Report to Manufacturer: 03/14/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2024
• 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