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

Catalog Number	80085007
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer contact, "hand injection 3 way tap + syringe were well connected at beginning of case then syringe started to become loose and untwist off the manifold during pci.Manifold changed but still issue occurred.Entire kit changed however same issue occurred with new set." due diligence has been completed.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.The sample was requested for evaluation.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 customer contact, "hand injection 3 way tap + syringe were well connected at beginning of case then syringe started to become loose and untwist off the manifold during pci.Manifold changed but still issue occurred.Entire kit changed however same issue occurred with new set.".
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- NAMIC; 10 glens falls technical park; glen falls NY 12801 3864
• Manufacturer Contact: alexa huskisson ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24491122
• Report Number: 3015910259-2026-00057
• Device Sequence Number: 21504160
• Product Code: DXT
• UDI-Device Identifier: 10193489066838
• UDI-Public: 10193489066838
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 03/02/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown