MAUDE Adverse Event Report: CARDINAL HEALTH 1ML MAGELLAN 25 X 1 COMBO; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881811510
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a needle-syringe malfunction has occurred while injecting the vaccine to a patient resulting in the patient not receiving the full intended amount of the vaccine.The liquid spilled on patient's arm only.Only a very small amount of vaccine reached the patient, exact amount is unknown, likely more than 90% amount was spilled.The patient was accompanied by their mother and is aware of the situation.The lvn tightened the syringe attachment to the needle prior to drawing, and after drawing to ensure the injection is tight.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.No physical sample was returned for evaluation.A photograph of a single blister strip package was provided but did not show any product problems.Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending purposes.

• Brand Name: 1ML MAGELLAN 25 X 1 COMBO
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 1222 sherwood rd; norfolk NE 68701
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 19012776
• Report Number: 1915484-2024-00007
• Device Sequence Number: 3809591
• Product Code: FMI
• UDI-Device Identifier: 10884521005891
• UDI-Public: 10884521005891
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 04/29/2024

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
• Operator of Device: Health Professional
• Device Model Number: 8881811510
• Device Catalogue Number: 8881811510
• Device Lot Number: P122153X
• 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: 03/13/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 04/29/2024
• Date Device Manufactured: 07/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown