MAUDE Adverse Event Report: CARDINAL HEALTH MONOJCT 35ML SYR L-LOCK; SYRINGE, PISTON

Model Number	1183500777
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that monoject 35ml syringes are an option that is allowed in their carefusion syringe infusion pumps.They stock both covidien monoject 35ml and cardinal monoject 35ml.Neonatal intensive care nurses recognized that the cardinal version was slightly different, and when both syringes were pulled back to the same value, the plunger of the cardinal brand syringe was extended further.This causes the pump to overestimate how much medication is left in the syringe.In addition, this mismatch is likely causing erroneous doses to be administered (if the barrel size is different on the inside).While this may be irrelevant in majority of patient care situations, it is very concerning in populations that are receiving very small doses, like their neonates.
Additional Manufacturer Narrative
The reported issue has been confirmed and a capa-crp-03163 has been initiated to further investigate.In addition, the reported device is part of a recall, event-2023-05729/res 93075.Please refer to the recall for additional details.
Additional Manufacturer Narrative
After a thorough review of the information received from the customer, it has been determined that this reported event does not meet the criteria for reporting as a serious injury and this report was filed in error.There was no patient harm, medical intervention, or details reported by the customer which indicate the patient was in substantial risk of a serious injury at the time of the event.If additional details are received, the reportability decision shall be re-evaluated.

• Brand Name: MONOJCT 35ML SYR L-LOCK
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 17732674
• Report Number: 1282497-2023-10791
• Device Sequence Number: 6542981
• Product Code: FMF
• UDI-Device Identifier: 10192253034691
• UDI-Public: 10192253034691
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1183500777
• Device Catalogue Number: 1183500777
• Device Lot Number: 221201
• 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: 09/05/2023
• Supplement Date Received by Manufacturer: 09/05/2023; 09/05/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 02/12/2024; 03/13/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown