MAUDE Adverse Event Report: Medline Industries, LP NAMIC; MMII,MP,3V,200S,RH,OFF,OEM

Catalog Number	80038301
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Ventricular Fibrillation (2130); Hemodynamic instability (4868)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "during the angioplasty part of the procedure (using second pk) the syringe and manifold started becoming loose.".
Additional Manufacturer Narrative
The account reported that during the angioplasty part of the procedure, the syringe and manifold started becoming loose; when the connection became loose there was backflow of blood and the arterial pressure dropped which confused the staff and the patient's condition deteriorated.No sample or photo was received for the investigation, and finished good production records were reviewed with no line-down situations, deviations, run-without, or non-conformance reports that would have had an impact on this issue.Medline confirmed that the reported issue is related to medline recall r-26-025, involving namic angiographic control syringes with rotating adaptor.The rotating adaptor may unwind during use, which can result in a loose connection or disconnection from the manifold; the division will monitor this issue for trending purposes, 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,3V,200S,RH,OFF,OEM
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: vamshi pinnamshetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50945563
• Report Number: 1417592-2026-54102
• Device Sequence Number: 13149643
• Product Code: DTL
• UDI-Device Identifier: 10193489066500
• UDI-Public: 10193489066500
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 09/29/2026

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: 80038301
• Device Lot Number: 0000138736
• Was Device Available for Evaluation?: Yes
• 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: 01/28/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown