MAUDE Adverse Event Report: Cardinal Health, Inc. Magellan; Needle, Hypodermic, Single Lumen

Model Number	8881850810
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction

• Brand Name: Magellan
• Common Device Name: Needle, Hypodermic, Single Lumen
• Manufacturer (Section D): Cardinal Health, Inc.; 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: 50779402
• Report Number: 1423537-2026-00289
• Device Sequence Number: 13246712
• Product Code: FMI
• UDI-Device Identifier: 10884521000582
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: 8881850810
• Device Catalogue Number: 8881850810
• Device Lot Number: 25M134
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• 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