MAUDE Adverse Event Report: CARDINAL HEALTH, INC. MONOJECT; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	1188825112
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/21/2024
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 the needles don't have a snug fit on the syringes.The doctor went to inject, and the fluid splashed him in the eyes.The customer stated it is not just the needle reported but other sizes as well however no other information was provided or able to be obtained.
Additional Manufacturer Narrative
The device history record (dhr) could not be reviewed as no lot information was provided within the complaint.Prior to a lot¿s release, the lot must be deemed acceptable by-passing inspections that are based on a valid sampling plan.During production, inspectors routinely examine a statistical sample both physically and visually.There were no samples returned for evaluation; therefore, the affected device(s) could not be evaluated to confirm the reported failure mode.As such, a root cause could not be determined.We will continue to monitor related reports to determine if additional actions are necessary.

• Brand Name: MONOJECT
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 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: 20846864
• Report Number: 1423537-2024-00332
• Device Sequence Number: 11705011
• Product Code: FMI
• UDI-Device Identifier: 10884521007383
• UDI-Public: 10884521007383
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K854547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2024

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: 1188825112
• Device Catalogue Number: 1188825112
• 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: 11/21/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 12/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown