MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; COMP,3V,200S,RH,ON,OEM,PG

Catalog Number	80058308
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "when using the contrast injector (200 psi of pressure), the luer lock tip of the manifold broke off.".
Additional Manufacturer Narrative
The customer reported that, when using the contrast injector at 200 psi of pressure, the luer lock tip of the manifold broke off.No sample or photo was received for the investigation; finished good production records and finished good pack build were reviewed, and no line-down situations, run without approvals, deviations, non-conformance reports, bom changes, or placement changes were identified that might have contributed to the reported defect.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.A root cause was not determined; the cause was listed as sample required to determine cause, and the division will monitor this issue for trending purposes.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: MEDLINE
• Common Device Name: COMP,3V,200S,RH,ON,OEM,PG
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: abdul khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50884338
• Report Number: 1417592-2026-49992
• Device Sequence Number: 21317135
• Product Code: DRS
• UDI-Device Identifier: 10193489066715
• UDI-Public: 10193489066715
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K902472
• 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): 09/23/2026

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: 80058308
• Device Lot Number: 0000150907
• 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: 10/09/2025
• Initial Report FDA Received Date: 09/24/2026
• 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