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

Model Number 8881513231

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/28/2023

Event Type  malfunction  

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 312413072
• Report Number: 1017768-2023-01049
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 20884521012711
• UDI-Public: 20884521012711
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• 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
• Date Manufacturer Received: 03/28/2023
• 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