MAUDE Adverse Event Report: CARDINAL HEALTH MONOJCT 20ML SYR L-LOCK; SYRINGE, PISTON

Model Number	1182000777
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
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 item is leaking on the top when the syringe is used.Additional information received stated it is leaking out of the connection of the luer.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed showing product and specification requirements were met with no non-conforming product identified.No samples or photographs were received for analysis.A complete investigation cannot be performed without a sample or photo, and the reported condition cannot be confirmed.A definitive root cause cannot be determined at this time.Complaint trends are evaluated during monthly meetings to determine if a corrective and preventative action (capa) is warranted.At this time, a capa will not be initiated.This complaint will be used for tracking and trending purposes.

• Brand Name: MONOJCT 20ML SYR L-LOCK
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 1222 sherwood rd; norfolk NE 68701
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 18149168
• Report Number: 1915484-2023-01329
• Device Sequence Number: 6614057
• Product Code: FMF
• UDI-Device Identifier: 10884521010802
• UDI-Public: 10884521010802
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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): 12/27/2023

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: 1182000777
• Device Catalogue Number: 1182000777
• Device Lot Number: 313543X
• 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: 11/09/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 12/27/2023
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown