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

Model Number	8881850558
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	10/15/2025
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 the new needle replacement for back ordered 25g 5/8 branded magellan lot 23k131 was very difficult to uncap.Prior needle of same lot uncapped but sheathed itself with cap removal prior to injection to patient.Staff used significant force to remove cap and in process stabbed left thumb of staff.Bleeding in glove, no harm to patient.Needle replaced and injection given to patient.Additional information received on 27nov2025 stated that the staff member received first-aid (i.E., self-care, pressure to wound, cleaned and band-aid).There was no blood draw or prophylactic medication since the incident occurred prior to patient.
Additional Manufacturer Narrative
The device history record (dhr) for lot 23k131 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.There were no samples returned for evaluation; therefore, the affected device could not be evaluated to confirm the reported failure.As such, a root cause could not be determined.We will continue to monitor reports and take actions as applicable.

• Brand Name: MAGELLAN
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): CARDINAL HEALTH; 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: 23771273
• Report Number: 1423537-2025-00495
• Device Sequence Number: 15869872
• Product Code: FMI
• UDI-Device Identifier: 10884521000575
• UDI-Public: (01)10884521000575(17)280731(10)23K131
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K012736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2026

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: 8881850558
• Device Catalogue Number: 8881850558
• Device Lot Number: 23K131
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 02/24/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown