MAUDE Adverse Event Report: CARDINAL HEALTH 3ML SYRINGE 22G X 1 RP; SYRINGE, PISTON

Model Number	8881513231
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported it looks like the rubber plungers melted or something.When they tried to pull up a vaccine the contents dripped out of the plunger side of the syringe.They kind of looked flipped to the side.
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 able to confirm the event, and determined that: the device history record was reviewed and indicated that the product was released accomplishing all quality standards.Five unused samples were returned for evaluation and the reported issue was seen during visual evaluation.A review of all available information was unable to determine an exact root cause.No corrective actions required at this time.All information received will be used for further tracking and trending purposes.

• Brand Name: 3ML SYRINGE 22G X 1 RP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 2010 east international speedw; deland FL 32724
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 16637657
• Report Number: 1017768-2023-01049
• Device Sequence Number: 6379849
• Product Code: FMF
• UDI-Device Identifier: 20884521012711
• UDI-Public: 20884521012711
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• 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
• Report Date (Section B): 08/28/2023

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: 8881513231
• Device Catalogue Number: 8881513231
• Device Lot Number: 22L052
• 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: 03/28/2023
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 08/28/2023
• 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