MAUDE Adverse Event Report: Cardinal Health 200, LLC MAGELLAN; Syringe, Piston

Model Number	8881833215
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction

• Brand Name: MAGELLAN
• Common Device Name: Syringe, Piston
• Manufacturer (Section D): Cardinal Health 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): Cardinal Health; 2010 east international speedw; deland FL 32724
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; +1(508)316-3640
• MDR Report Key: 50778231
• Report Number: 1423537-2026-00288
• Device Sequence Number: 16128594
• Product Code: FMF
• UDI-Device Identifier: 10192253024722
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K852544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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
• Device Model Number: 8881833215
• Device Catalogue Number: 8881833215
• Device Lot Number: 26D175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/15/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown