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

Model Number 8881512977

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 328026366
• Report Number: 9612030-2023-03860
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10192253030686
• UDI-Public: 10192253030686
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 11/13/2023
• Supplement Dates Manufacturer Received: 11/08/2023
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1