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

Model Number	8881850215
Medical Device Problem Code	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 that the product comes out next to the needle.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.There were no devices or photos provided for analysis.Based on the available information, the reported issue could not be observed, and an exact root cause was not determined.All information received will be used for further tracking and trending purposes and we will continue to monitor.

• 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: 20447140
• Report Number: 1423537-2024-00225
• Device Sequence Number: 8532389
• Product Code: FMI
• UDI-Device Identifier: 10884521000087
• UDI-Public: (01)10884521000087(17)241231(10)004115
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2024

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: 004115
• 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: 09/19/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 12/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown