MAUDE Adverse Event Report: Medline Industries, LP NAMIC; MMII,MP,2V,200S,RH,OFF,OEM

Catalog Number	80038200
Medical Device Problem Code	Decoupling (1145)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "when connecting the syringe to the end of the manifold to inject contrast or flush the syringes are undoing themselves.Either the manifold, or the syringes in the medline angiogram pack are faulty.".
Additional Manufacturer Narrative
The facility reported that when connecting the syringe to the end of the manifold to inject contrast or flush the syringes are undoing themselves, and that either the manifold, or the syringes in the medline angiogram pack are faulty.No sample or photo was received for the investigation; finished good production records were reviewed and there were no line-down situations, no run without approvals, deviations or non-conformance reports that might have had an impact on this issue.At this time, medline was unable to confirm the reported defect, as no physical sample or detailed photographic evidence was provided to support the investigation; the cause code was sample required to determine cause.There was no confirmed medical intervention or serious injury reported related to this incident, and there has been no change to the reportability decision associated with this complaint.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: NAMIC
• Common Device Name: MMII,MP,2V,200S,RH,OFF,OEM
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: william abrams ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50913679
• Report Number: 1417592-2026-51824
• Device Sequence Number: 5393989
• Product Code: DTL
• UDI-Device Identifier: 10193489066456
• UDI-Public: 10193489066456
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K2095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 80038200
• Device Lot Number: 0000136432
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown