MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; CARDIAC CATH TRAY

Catalog Number	DYNJ45323F
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the control syringe(included in the tray pack) will not stay securely luer locked onto the 3-port manifold.Even after tightening the control syringe, it has come loose on its own.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.In an abundance of caution, and in response to an fda 483 issued for cfn (b)(4) on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
Control syringe not locking to manifold.
Additional Manufacturer Narrative
Updated: d4, e1, g6, h2.

• Common Device Name: CARDIAC CATH TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 19585992
• Report Number: 1423395-2024-00436
• Device Sequence Number: 15273690
• Product Code: OES
• UDI-Device Identifier: 40195327082360
• UDI-Public: 40195327082360
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: DYNJ45323F
• Device Lot Number: 24BMH826
• 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: 05/24/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown