MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NAMIC; MTS,3,PORT,RED,KIT-LEESBURG,REG MED CEN

Catalog Number	60122271
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility, the syringe that attaches to the manifold will loosen/detach during care even if the staff tightens before use.
Additional Manufacturer Narrative
According to the facility, the syringe that attaches to the manifold will loosen/detach during care even if the staff tightens before use the syringe was being used for injecting a contrast/saline mixture during a cardiac catheterization.There have been several instances where this has happened, no reports of any cracks in either piece of equipment.The staff got another syringe to finish the case in some cases and in others they just reattached the syringe and continued to monitor syringe connection during case.Luckily staff noticed before any air could be introduced to the patient through the line.There was no impact to the patient and the procedure was completed.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)(6); 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.
Additional Manufacturer Narrative
Update to b3: date of event.Update to d9: device returned.Update to h3: device evaluated.Update to h6: type of investigation.Update to h6: investigation findings.Update to h6: investigation conclusions.

• Common Device Name: MTS,3,PORT,RED,KIT-LEESBURG,REG MED CEN
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NAMIC; 10 glens falls technical park; glens falls NY 12801 3864
• Manufacturer Contact: danielle pohlman ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 21161999
• Report Number: 3015910259-2025-00002
• Device Sequence Number: 8433681
• Product Code: OEZ
• UDI-Device Identifier: 20193489046141
• UDI-Public: 20193489046141
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/12/2026

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 Catalogue Number: 60122271
• Device Lot Number: 0000137496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown