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

Model Number	8881200318
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section e1 - e-mail: (b)(6).An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the df was having difficulty with those needles attaching to an arthramid syringe.Per customer, if the customer uses a 20g needle he does not have product loss and when he uses 21g, he always has a drop escape the needle/hub connection and was concerned there may have been a manufacturing issue.There was no harm reported.
Additional Manufacturer Narrative
The following sections were updated or answered: d1 brand name.D3 manufacturer name and address.D4 unique identifier (udi) #.G4 pma/510(k)number.H6 evaluation codes.Investigation summary: the device history record (dhr) for lot: 22h111 was reviewed and no anomalies related to the reported issue were observed.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 ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 18628080
• Report Number: 1017768-2024-00007
• Device Sequence Number: 18083347
• Product Code: FMI
• UDI-Device Identifier: 30884521008384
• UDI-Public: (01)30884521008384(10)22H111
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

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: 8881200318
• Device Catalogue Number: 8881200318
• Device Lot Number: 22H11
• 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: 01/19/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 01/02/2025
• 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