MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NAMIC; SYRINGE,10ML,TR/FR,MLL,W/RES

Catalog Number	70085003
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that on (b)(6) 2025 the syringe "could not be connected to the manifold." the customer reported the issue occurred "during the preparation stage" and that there was no patient involvement.The customer stated that "other products were used" and that "it is suspected that the user is using it incorrectly." 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 on (b)(6) 2025 the syringe "could not be connected to the manifold." the customer reported the issue occurred "during the preparation stage" and that there was no patient involvement.The customer stated that "other products were used" and that "it is suspected that the user is using it incorrectly.".
Additional Manufacturer Narrative
Update to h6: investigation findings (c).Update to h6: investigation conclusions (d).

• Common Device Name: SYRINGE,10ML,TR/FR,MLL,W/RES
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NAMIC; 10 glens falls technical park; glens falls NY 12801 3864
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 23878713
• Report Number: 3015910259-2025-00114
• Device Sequence Number: 4671646
• Product Code: DXT
• UDI-Device Identifier: 10193489065923
• UDI-Public: 10193489065923
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/29/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2026
• Device Catalogue Number: 70085003
• Device Lot Number: 0000075375
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2023
• 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