MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; QUICK SWITCH VALVE, STERILE

Catalog Number	ENFIT9000S
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer the "quick switch enfit valve was leaking tf, flushes, and medication".The customer reported that the valve was removed immediately and there was "no real impact" on the patient due to the quick response.The customer did not report any serious injury, medical intervention, or follow up care related to the reported incident.No additional information is available at this time.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 medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer the "quick switch enfit valve was leaking tf, flushes, and medication".The customer reported that the valve was removed immediately and there was "no real impact" on the patient due to the quick response.

• Brand Name: MEDLINE
• Common Device Name: QUICK SWITCH VALVE, STERILE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle pohlman ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24326891
• Report Number: 1417592-2026-00112
• Device Sequence Number: 21323748
• Product Code: PIF
• UDI-Device Identifier: 10193489012569
• UDI-Public: 10193489012569
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/12/2026

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 Expiration Date: 06/01/2026
• Device Catalogue Number: ENFIT9000S
• Device Lot Number: 89723060001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown