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

Model Number	8881513223
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
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 that they used the 3ml syringe to draw up cytopoint for a pet.They used a 30mg vial and two 40mg vials however 1 ml of the medication leaked out around the syringe, despite being tightly attached.
Additional Manufacturer Narrative
On 17sep2024 a syringe was returned for evaluation as part of our investigation process.Upon initial review of the returned device, it was determined that the returned device was not a 3ml syringe manufactured by cardinal health as originally reported.Instead, it was a 6ml syringe by terumo.Confirmation was requested from the initial reporter whom confirmed the incident syringe was the device returned for evaluation.It was also confirmed that the incident did indeed involve a 6ml syringe, not the 3ml syringe originally reported.Based on this information, this complaint will be considered closed as the true complaint device is not manufactured by cardinal health.No further reports will be forwarded for this event.

• 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; 2010 east international speedw; deland FL 32724
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 20159210
• Report Number: 1423537-2024-00146
• Device Sequence Number: 8301703
• Product Code: FMF
• UDI-Device Identifier: 20192253037774
• UDI-Public: 20192253037774
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K852544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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
• Operator of Device: Health Professional
• Device Model Number: 8881513223
• Device Catalogue Number: 8881513223
• 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: 09/05/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 09/23/2024
• 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
• Patient Sex: Unknown