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	Insufficient Information (4580)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, "i went into my patient's room and noticed that tube feed was leaking from the tube feed stop cock".The facility stated the device did not completely break but it is leaking.The facility reported that the lot number was "10193489012569" however this is an invalid lot number for this product.There was no further information.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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 facility, "i went into my patient's room and noticed that tube feed was leaking from the tube feed stop cock".The facility stated the device did not completely break but it is leaking.

• Brand Name: MEDLINE
• Common Device Name: QUICK SWITCH VALVE, STERILE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 24410814
• Report Number: 1417592-2026-00133
• Device Sequence Number: 10569515
• 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): 02/22/2026

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: ENFIT9000S
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 02/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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