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

Model Number 1182000777

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/07/2023

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 328289331
• Report Number: 1915484-2023-01329
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10884521010802
• UDI-Public: 10884521010802
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 11/09/2023
• Supplement Dates FDA Received: 12/27/2023
• Type of Device Usage: A
• Patient Sequence Number: 1