MAUDE Adverse Event Report: CARDINAL HEALTH, INC. MAGELLAN; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881850115
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported a hypodermic needle was found to be faulty mid-procedure.Patient was having im depot injection, needle inserted into intramuscular tissue, plunger depressed and fluid noted to be leaking out of proximal end of needle.Patient was underdosed as a result of this fault.Faulty product was not retained.
Additional Manufacturer Narrative
Section g3 date received by manufacturer was updated after confirmation from the cardinal health sales rep.
Additional Manufacturer Narrative
A non-conformance (nc) review was conducted for lot 201007 and there were no ncs related to the reported event issued during the manufacturing of this lot.Prior to a lot¿s release, the lot must be deemed acceptable by-passing inspections that are based on a valid sampling plan.During production, inspectors routinely examine a statistical sample both physically and visually.There were no device(s) returned for evaluation; therefore, the affected product(s) could not be evaluated to confirm the reported issue.As such, a root cause could not be determined.We will continue to monitor related reports to determine if additional actions are necessary.

• 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 ; 5086183640
• MDR Report Key: 21054878
• Report Number: 1423537-2025-00001
• Device Sequence Number: 7948120
• Product Code: FMI
• UDI-Device Identifier: 10884521000476
• UDI-Public: (01)10884521000476(17)261031(10)201007
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K012736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2025

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: 8881850115
• Device Catalogue Number: 8881850115
• Device Lot Number: 201007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2025
• Supplement Date Received by Manufacturer: 12/30/2024; Not provided
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 01/02/2025; 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown