MAUDE Adverse Event Report: CARDINAL HEALTH, INC. MONOJECT; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	8881540133
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the nurse was needing to draw up medication so she obtained a 3 ml syringe with needleless needle.Nurse removed syringe from package, removed needle cap, and inserted the needle into the vial.When starting to draw up, the fluid leaked around the area where the needle attaches with luer lock to the syringe.The needle was not on tight which caused the leakage.This issue happens with most of these syringes that the needle is not fully attached.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The following sections were updated or answered: d1 brand name; d3 manufacturer name and address; d4 unique identifier (udi) #; d4 expiration date; g4 pma/510(k)number; h6 evaluation codes.Investigation summary: the device history record (dhr) for lot 23g052 was reviewed and no anomalies related to the reported issue were observed.Prior to a lot¿s release, the lot must be deemed acceptable by-passing inspections that are based on a valid sampling plan.During production, inspectors routinely examine a statistical sample both physically and visually.There were no samples returned for evaluation, therefore the affected device(s) could not be evaluated to confirm the reported failure mode.As such, a root cause could not be determined.We will continue to monitor related reports to determine if additional actions are necessary.

• Brand Name: MONOJECT
• Common Device Name: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• 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: 18610982
• Report Number: 1017768-2024-00006
• Device Sequence Number: 11372890
• Product Code: GEA
• UDI-Device Identifier: 10884521082946
• UDI-Public: (01)10884521082946(17)280430(10)23G052
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

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
• Operator of Device: Health Professional
• Device Model Number: 8881540133
• Device Catalogue Number: 8881540133
• Device Lot Number: 23G052
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown