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

Model Number	8881850510
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
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 their flu clinic encountered some issues yesterday with the 25gx1in safety needle, 8881850510.They were randomly leaking during administration.Staff made sure the needle and syringe were tight.
Additional Manufacturer Narrative
Additional information was received from the customer on 23oct2024.Based on the additional information, b5 was updated.
Event or Problem Description
The customer reported their flu clinic encountered some issues yesterday with the 25gx1in safety needle, 8881850510.They were randomly leaking during administration.Staff made sure the needle and syringe were tight.They had 3 out of 30 leak, same lot number, different boxes.Additional information provided on 23oct2024 stated that the syringes being used are prefilled fluarix by gsk 58160-884-52.The leak was at the connection between the syringe and the needle.
Additional Manufacturer Narrative
The device history record (dhr) for lot 120854 was reviewed and no anomalies related to the reported issue were observed.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.Unused samples were received and evaluated; the reported issue was not confirmed.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: 20499600
• Report Number: 1423537-2024-00252
• Device Sequence Number: 7612369
• Product Code: FMI
• UDI-Device Identifier: 10884521000568
• UDI-Public: (01)10884521000568(17)260531(10)120854
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K012736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2025

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 Expiration Date: 05/31/2026
• Device Model Number: 8881850510
• Device Catalogue Number: 8881850510
• Device Lot Number: 120854
• 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: 10/18/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 10/28/2024; 03/24/2025
• 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