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

Model Number	8881850510
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	12/10/2025
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 that they have been experiencing safety concerns and also a needle stick with the cardinal magellan hypodermic safety needle 25g x 1¿, 8881850510, lot 25g254.This needle is being used as a sub for the backordered bd needle 305916.The practice has noted the product has a defective safety lock on the needles and have experienced on multiple different uses that when closing the safety mechanism, the needle has remained out.The needle will also bend forward and miss the safety lock all together, overall, they are flimsy and poor quality.These needles are being used for im injections.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.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.The lot met all defined acceptance requirements and was released.One device was received for investigation.The device was evaluated; the safety shield was activated and closed properly, securing the needle.The sample did not confirm the reported condition.The investigation did not identify a systemic issue with the product or process.Therefore, a corrective and preventive action is not necessary at this time.We will continue to monitor related reports to determine if additional actions are necessary.

• Brand Name: CARDINAL HEALTH, INC.
• 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: 23896061
• Report Number: 1423537-2025-00519
• Device Sequence Number: 5331889
• Product Code: FMI
• UDI-Device Identifier: 10884521000568
• UDI-Public: (01)10884521000568(10)300531(17)25G254
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

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: 8881850510
• Device Catalogue Number: 8881850510
• Device Lot Number: 25G254
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown