MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC MONOJECT LUER-LOCK TIP SYRINGE; SYRINGE, PISTON

Model Number	1182000777
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Our hospital uses monoject syringes.Monoject syringes were previously manufactured by covidien.They have recently changed to cardinal health.Cardinal health is using the same reference number and monoject name but the syringes are different.The reason this is an issue is because we use the monoject syringes on our medfusion pumps.The medfusion pumps are programmed with the parameters of the syringe.Now, when you put your monoject syringe on the medfusion pump it can't be recognized.We have reported this issue to cardinal health but no resolution yet.I am concerned because hospitals across the country use medfusion syringe pumps and when they go to run a potentially life sustaining medication with a cardinal health monoject syringe it will not work on the syringe pumps.It seems that cardinal health should notify all of it's customers of this issue.

• Brand Name: MONOJECT LUER-LOCK TIP SYRINGE
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC
• MDR Report Key: 17691889
• Report Number: MW5145205
• Device Sequence Number: 15333800
• Product Code: FMF
• UDI-Device Identifier: 10192253034677
• UDI-Public: 10192253034677
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 08/30/2023

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
• Operator of Device: Health Professional
• Device Model Number: 1182000777
• Device Lot Number: 221201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MEDFUSION PUMP.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown