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)
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 when the provider uses the syringe to administer medication it is coming out of the top side of the syringe, no proper seal on the syringe.The customer was not able to provide the affected quantity or the exact lot(s) stating that the product is spread throughout their facility and this has been a continual issue with these for a long period of time.
Additional Manufacturer Narrative
Based on the information available to us, we were unable to confirm the event.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 02048
• 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: 18126943
• Report Number: 9612030-2023-03860
• Device Sequence Number: 6403606
• 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
• 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: 11/08/2023
• Supplement Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 04/18/2024
• 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