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

Catalog Number	80087007
Medical Device Problem Code	Loose or Intermittent Connection (1371)
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".As a result, the facility stated that "other syringes used from own stock".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.Due to the reported problem/issue, and in an abundance of caution, an adverse event report will be filed.If additional information becomes available this report will be reopened and reevaluated.
Event or Problem Description
It was reported that the syringe "doesn't tighten to seal and come off at tightening point".As a result, the facility stated that "other syringes used from own stock".The customer did not report any incidents of patient injury related to the reported incident.
Additional Manufacturer Narrative
Update to h6, h7, and h9.After further investigation, it has been determined that the device was not returned, and the investigation involved an analysis of production records.The investigation identified a manufacturing process problem, and the investigation concluded that a manufacturing deficiency occurred related to recall r-26-025.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: MEDLINE
• Common Device Name: SYRINGE,12ML,TR/FR,RA,OEM
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NAMIC; 10 glen falls technical park; glen falls NY 12801
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 24404940
• Report Number: 3015910259-2026-00029
• Device Sequence Number: 10113906
• 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 80087007
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/24/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown