MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NAMIC MEDLINE; SYRINGE,12ML,TR/FR,RA,OEM

Catalog Number	80087007
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the syringe "doesn't tighten to seal and come off at tightening point".The customer did not report any incidents of patient injury related to the reported incident.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 the syringe "doesn't tighten to seal and come off at tightening point".The customer did not report any incidents of patient injury related to the reported incident.
Additional Manufacturer Narrative
Updated: b4, g3, g6, h2, h6, h7, h9.

• Brand Name: MEDLINE
• Common Device Name: SYRINGE,12ML,TR/FR,RA,OEM
• 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 60093-2753
• MDR Report Key: 24401782
• Report Number: 3015910259-2026-00028
• Device Sequence Number: 21296810
• Product Code: DXT
• UDI-Device Identifier: 10193489066852
• UDI-Public: 10193489066852
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K873955
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2026

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: 80087007
• 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: 01/23/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 04/13/2026
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: R-26-025
• Patient Sequence Number: 1
• Patient Sex: Unknown