MAUDE Adverse Event Report: MEDLINE INDUSTRIES - 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	02/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that "manifold and syringe connection was a bit loose from the beginning, when filled with contrast the syringe was totally loose and screwed out itself".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
Loose syringe to manifold connection.

• Brand Name: MEDLINE
• Common Device Name: SYRINGE,10ML,ANGIO,W/RA,-,OEM
• Manufacturer (Section D): MEDLINE INDUSTRIES - NAMIC; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24499703
• Report Number: 3015910259-2026-00061
• Device Sequence Number: 15981535
• 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): 03/03/2026

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: 0000156801
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 03/03/2026
• Date Device Manufactured: 03/03/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown