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

Model Number	8881850215
Medical Device Problem Codes	Break (1069); Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 broken needle on the safety needle.The product information was not provided.
Additional Manufacturer Narrative
Samples were not received for the investigation.A device history record review could not be performed because a lot number was not received with the complaint.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine the root cause, therefore a corrective action is not applicable at this time.If a sample is received at a later date, this complaint will be reopened for further investigation.This complaint will be used for tracking and trending purposes.
Event or Problem Description
The customer reported a broken needle on the safety needle.On 09jun2024 the customer provided additional information stating that when placing the depot, fluid leaked through the bottom of the needle (where it is screwed onto the syringe).On (b)(6) 2024, one syringe was received in teva kfar saba in an open original product box.The syringe was observed inside the blister with a 22g needle close by.A 23g needle was not observed inside the box.The syringe was received with a low fill volume.Residues of the solution were observed inside the blister.The syringe was visually inspected and found to be intact, without breaks and/or cracks.A crack was observed in the needle, in the plastic part that connects to the syringe.
Additional Manufacturer Narrative
Additional event information was received from the customer on 09jun2024 therefore sections b5, d1 and d4 were updated.Based on additional information received, h6 medical device problem code was corrected.
Additional Manufacturer Narrative
Investigation summary: based on the information available to us, we were able to confirm the event and determined that: although no samples were returned for evaluation, the provided pictures were evaluated and there was a picture showing a crack in the hub.The pictures did not show leakage.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The lot was produced between 28feb2020 and 05mar2020.The investigation did not identify a systemic issue with the product or process and a specific root cause could not be identified based on available information.Therefore, a corrective and preventive action (capa) is not necessary at this time.All information received will be used for further tracking and trending purposes.
Additional Manufacturer Narrative
The device history record (dhr) for lot 004871 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.One safety needle was returned for evaluation and the reported issue was observed.However, the investigation did not identify a systemic issue with the product or process.A specific root cause could not be identified based on available information.Therefore, a corrective and preventive action (capa) is not necessary at this time.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.; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 2010 east international speedw; deland FL 32724
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 18909151
• Report Number: 1017768-2024-00023
• Device Sequence Number: 6886450
• Product Code: FMI
• UDI-Device Identifier: 10884521000087
• UDI-Public: (01)10884521000087(17)241231(10)004871
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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,Followup,Followup,Followup
• Report Date (Section B): 09/18/2025

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: 12/31/2024
• Device Model Number: 8881850215
• Device Catalogue Number: 8881850215
• Device Lot Number: 004871
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 05/31/2024; 06/12/2024; 08/20/2024; 09/18/2025
• 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