MAUDE Adverse Event Report: CARDINAL HEALTH MAGELLAN 1/2 ML INSULIN SAFETY SYRINGE; SYRINGE, PISTON

Model Number	8881893050
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Recent reports from staff of the 1/2 ml insulin safety syringes not being good quality.There are many complaints that the needle will fold when attempting to draw up insulin or poke through the cap when re-capping.The staff have said they can be dangerous to use.Staff have to be extra careful when handling them because they bend so easily, and the cap does not stay on well.

• Brand Name: MAGELLAN 1/2 ML INSULIN SAFETY SYRINGE
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 18491452
• Report Number: 18491452
• Device Sequence Number: 3664965
• Product Code: FMF
• UDI-Device Identifier: 10884521005976
• UDI-Public: (01)10884521005976
• 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): 12/06/2023
• Report Date (Section F): 12/06/2023

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: 8881893050
• Device Catalogue Number: 8881893050
• Device Lot Number: 326529X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/11/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/11/2024
• 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: 12/06/2023