MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NAMIC; DBD-MTS,LEFT,HRT-ST.FRANCIS

Catalog Number	60060201
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that there have been "multiple" incidents where the syringe is "un-swiveling from the manifold" prior to use on a patient for a "heart cath" procedure.The customer reported that a new syringe was obtained, and the procedures have been able to be completed.No additional details are available related to the customer reported issue.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
It was reported that there have been multiple incidents where the syringe is un-swiveling from the manifold prior to use on a patient for a heart cath procedure.
Additional Manufacturer Narrative
Update to b1 and h6.After further investigation, it has been determined that the issue is a product problem.The investigation included testing of the actual and suspected device, review of production records, and trend analysis.An interoperability problem was identified, and the cause was traced to a manufacturing deficiency.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: DBD-MTS,LEFT,HRT-ST.FRANCIS
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NAMIC; 10 glen falls technical park; glen falls NY 12801 3864
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 22790567
• Report Number: 3015910259-2025-00058
• Device Sequence Number: 8264744
• Product Code: OEZ
• UDI-Device Identifier: 10193489043594
• UDI-Public: 10193489043594
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 60060201
• Device Lot Number: 0000153003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Supplement Date Received by Manufacturer: 02/15/2026
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 03/10/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown