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

Catalog Number	80085007
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that "the syringe unscrewed off the manifold and became loose several times allowing contrast bubbles to form in the connection point." per the customer contact, after a new manifold was prepared the syringe once again came off the manifold and the procedure ceased shortly after.The sample was requested for evaluation.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
It was reported that "the syringe unscrewed off the manifold and became loose several times allowing contrast bubbles to form in the connection point." per the customer contact, after a new manifold was prepared the syringe once again came off the manifold and the procedure ceased shortly after.
Additional Manufacturer Narrative
Update to h6: investigation findings (c).Update to h6: investigation conclusions (d).Update to h7: if remedial action initiated, check type.Update to h9: if action reported to fda under 21 usc 360i(g), list correction/removal reporting number.

• Brand Name: MEDLINE
• Common Device Name: SYRINGE,10ML,ANGIO,W/RA,-,OEM
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 10 glen falls; technical park drive; glenn falls NY 12801 3864
• Manufacturer Contact: alexa huskisson ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24526167
• Report Number: 3015910259-2026-00071
• Device Sequence Number: 8522628
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• 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