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	Feeding Problem (1850)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility, "quick switch valve with eenfit connector broken.Leaking tube feeds onto bedsheet.Leaking tube feeds can interrupt nutritional intake, effect blood sugars (especially for those on insulin drip) and necessitates changing the sheets which can be difficult for patients who are hemodynamically unstable with ecmo and impella devices." the facility did not provide any 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, "quick switch valve with eenfit connector broken.Leaking tube feeds onto bedsheet.Leaking tube feeds can interrupt nutritional intake, effect blood sugars (especially for those on insulin drip) and necessitates changing the sheets which can be difficult for patients who are hemodynamically unstable with ecmo and impella devices.".

• Brand Name: MEDLINE
• Common Device Name: QUICK SWITCH VALVE, STERILE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 3 lakes dr; northfield IL 60093
• Manufacturer Contact: alyssa reasner ; 3 lakes dr; northfield, IL 60093
• MDR Report Key: 24324425
• Report Number: 1417592-2026-00111
• Device Sequence Number: 13263201
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ENFIT9000S
• 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
• 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