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 Date 11/07/2023

Event Type  malfunction  

Event 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.

Manufacturer Narrative

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

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
• Type of Device: 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
• MDR Text Key: 329384946
• Report Number: 9612030-2023-03874
• 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
• 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
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 11/13/2023
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1