MAUDE Adverse Event Report: CARDINAL HEALTH, INC. MAGELLAN; SYRINGE, PISTON

Model Number	8881833215
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
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 while pulling up medicine the medicine shot out from the side of the syringe onto patient's arm.
Additional Manufacturer Narrative
Additional information was received on 16jul2024 stating that that there was a hole/crack in the barrel.Section b5 was updated accordingly.
Event or Problem Description
The customer reported that while pulling up medicine the medicine shot out from the side of the syringe onto patient's arm.Additional information received on 16jul2024 stated that there was a hole/crack in the barrel.
Additional Manufacturer Narrative
Investigation summary: samples were not received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.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 a root cause.A corrective action is not applicable at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: MAGELLAN
• Common Device Name: SYRINGE, PISTON
• 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: 19649731
• Report Number: 1423537-2024-00057
• Device Sequence Number: 6550054
• Product Code: FMF
• UDI-Device Identifier: 10884521005792
• UDI-Public: (01)10884521005792(17)280831(10)23M140
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/28/2024

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 Model Number: 8881833215
• Device Catalogue Number: 8881833215
• Device Lot Number: 23M140
• 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: 06/25/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 07/16/2024; 10/28/2024
• 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