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	07/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One photograph was provided for evaluation and the reported issue of a crack was observed, but leaking was not observed in the photograph.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Without a physical sample, it is not possible to determine an exact root cause.No actions are applicable at this time.All information received will be used for tracking and trending purposes.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported, that three, so far out of the box cracked down syringe.Additional information received on 29jul2024.Stated, that the crack went more than half way down the barrel.The syringe leaked out whatever was drawn up.

• 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: 19860612
• Report Number: 1423537-2024-00090
• Device Sequence Number: 12787846
• Product Code: FMF
• UDI-Device Identifier: 20192253037774
• UDI-Public: (01)20192253037774
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/05/2024

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: 8881513223
• Device Catalogue Number: 8881513223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2024
• Supplement Report FDA Received Date: 11/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown