MAUDE Adverse Event Report: MEDLINE-NAMIC MEDLINE; SYRINGE,10ML,ANGIO,W/RA,-,OEM

Catalog Number	80085007
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, "the ring grip syringe keeps "untwisting" from the manifold.We threw out the ring grip syringe for a new one without any change.Just letting the syringe fill with saline was enough pressure to disconnect it.There was no adverse outcome to the patient".There was no further information.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, "the ring grip syringe keeps "untwisting" from the manifold.

• Brand Name: MEDLINE
• Common Device Name: SYRINGE,10ML,ANGIO,W/RA,-,OEM
• Manufacturer (Section D): MEDLINE-NAMIC; 10 glens falls technical park; glens falls NY 12801 3864
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24690455
• Report Number: 3015910259-2026-00099
• Device Sequence Number: 13188257
• Product Code: DXT
• UDI-Device Identifier: 10193489066838
• UDI-Public: 10193489066838
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Type of Report: Initial
• Report Date (Section B): 03/25/2026

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: 80085007
• Device Lot Number: 0000161181
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2025
• 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