MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC MONOJECT; SYRINGE, PISTON

Model Number	8881513207
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported leakage of liquid (medications) through the plunger of the syringes.The problem may occur on more than half of the syringes in the same tray.On some syringes, the product leaks between the 2 theoretically sealed sections of the piston.On other syringes, the drug flows and comes out of the syringe from the plunger.The customer further stated that the syringes are not leak-proof and do not maintain the sterility of medications.Risk of drug loss (incomplete dose) and contamination of doses with microorganisms.In addition, the syringes are interposed inside the tray.This means that pharmacy dispensers cannot protect critical syringe sites easily (go over the syringe tips in the row below when trying to pick up syringes from the top row).This increases the risk of contaminating supplies during handing.They have lost many doses of medication because the medication had leaked into the plunger of the syringe (the product is no longer considered sterile).The doses have been redone.To solve this issue, they have changed the preparation of several drugs to 5ml syringes despite a risk that the volume will be less accurate.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.There were no samples or photos provided for analysis.Based on the available information, the reported issue could not be confirmed, and an exact root cause was not determined.All information received will be used for further tracking and trending purposes and we will continue to monitor.

• Brand Name: MONOJECT
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 20502203
• Report Number: 1423537-2024-00254
• Device Sequence Number: 8488284
• Product Code: FMF
• UDI-Device Identifier: 20192253030690
• UDI-Public: (01)20192253030690(10)2308200464
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K860688
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2024

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: 8881513207
• Device Catalogue Number: 8881513207
• Device Lot Number: 2308200464
• 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: 10/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 12/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown