MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NAMIC; MTS,CATH,LAB,KIT,-,UNITED HOSP CENTER,PG

Catalog Number	60210574
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility on 03/17/2025 "the syringe was being used in set up for a cardiac catheterization and would not tighten down to the manifold".Per the facility a separate syringe was used and fit to the manifold appropriately.Per the facility there was no patient involvement or injury reported.The syringe was returned for evaluation, and the cause has been determined to be customer use.No additional information is available at this time.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 1417592 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
According to the facility on (b)(6) 2025 "the syringe was being used in set up for a cardiac catheterization and would not tighten down to the manifold".

• Common Device Name: MTS,CATH,LAB,KIT,-,UNITED HOSP CENTER,PG
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NAMIC; 10 glens falls technical park; glens falls NY 12801 3864
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 21761432
• Report Number: 3015910259-2025-00026
• Device Sequence Number: 8490913
• Product Code: OEZ
• UDI-Device Identifier: 10193489052121
• UDI-Public: 10193489052121
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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
• Report Date (Section B): 04/03/2025

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 Catalogue Number: 60210574
• Device Lot Number: 0000143655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 04/03/2025
• 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