MAUDE Adverse Event Report: CARDINAL HEALTH 12ML CONTROL SYR 0.2ML INCR; SYRINGE, PISTON

Model Number	8881512977
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that when provider uses syringe to administer medication, it is coming out of the top side of syringe (no proper seal on syringe).Additional information received from the initial reporter on 15nov2023 stated that it appears the plunger does not seal to the syringe and fluid is able to bypass.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
Based on the information available to us, we were unable to confirm the event.The device history record review found no abnormal process conditions present during manufacturing that could have led to the reported issue.Samples were received and visually evaluated; the samples met product specification, there were no visually issues found.The samples were forwarded to the supplier for further review.In the meantime, all information received will be used for further tracking and trending purposes.

• Brand Name: 12ML CONTROL SYR 0.2ML INCR
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 18238725
• Report Number: 9612030-2023-03874
• Device Sequence Number: 16950633
• Product Code: FMF
• UDI-Device Identifier: 10192253030686
• UDI-Public: 10192253030686
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 04/18/2024

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: 8881512977
• Device Catalogue Number: 8881512977
• Device Lot Number: 2303825664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown