MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; QUICK SWITCH VALVE,NON-STERILE

Catalog Number	ENFIT9000NS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "when going to flush the tube, before uncapping one of the ports a crack noticed where the luer lock is.Another port used which ended up breaking.".
Additional Manufacturer Narrative
The customer complaint reported the enfit stopcock was defective, with a crack noticed where the luer lock is and another port ended up breaking.A sample of enfit9000ns was received from the customer; the sample was in a very used condition with the print on the valve plate slightly faded and dried formula in the connectors.Based on the sample provided, the reported issue was confirmed, and the breaks were located on both male enfit connectors with notable damage to one of the enfit caps that get inserted into the connector.The cause was documented as cannot determine cause with received sample, and the divisional quality representative will continue to monitor this issue for tracking and trending purposes during quarterly trending.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: QUICK SWITCH VALVE,NON-STERILE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: maya mcknight ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50946685
• Report Number: 1417592-2026-54311
• Device Sequence Number: 21238685
• Product Code: PIF
• UDI-Device Identifier: 20193489012559
• UDI-Public: 20193489012559
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K191759
• 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): 09/28/2026

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: ENFIT9000NS
• 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: 08/10/2023
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown