MEDLINE ENFIT9000SRecalls & reported problems
Medline Industries, Inc. · QUICK SWITCH VALVE, STERILE · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10193489012569), received between Jan 19, 2026 and Sep 22, 2026 — classified as 2 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak4
- Leak/Splash4
- Material Integrity Problem4
- Break3
- Crack2
- Fracture1
Patient problems
- Insufficient Information6
- No Clinical Signs, Symptoms or Conditions5
- Feeding Problem2
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Break
It was reported that "ENFit connector snapped off."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855071 ↗MalfunctionSep 21, 2026Break; Crack; Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841092 ↗MalfunctionSep 21, 2026Break; Crack; Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840444 ↗MalfunctionFeb 24, 2026Fluid/Blood Leak; Fracture
ACCORDING TO THE FACILITY, THE QUICK-SWITCH VALVE WITH AN ENFIT CONNECTOR REPORTEDLY BROKE OFF FROM THE MALE END THAT ATTACHES TO THE DOBHOFF TUBE. IT WAS ALSO NOTED THAT THE TUBE FEEDS HAD BEEN DRIPPING FROM THE SAME MALE END PRIOR TO THE BREAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24433121 ↗MalfunctionFeb 23, 2026Material Integrity Problem
MalfunctionFeb 23, 2026Material Integrity Problem
MalfunctionFeb 22, 2026Leak/Splash
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.
Patient problems: Insufficient Information
MAUDE report 24410814 ↗InjuryFeb 19, 2026Leak/Splash
ACCORDING TO THE FACILITY, "THE QUICK SWITCH VALVE WITH ENFIT CONNECTOR BROKE OFF FROM THE MALE END THAT CONNECTS TO DOBHOFF. TUBE FEEDS WERE DRIPPING FROM THE SAME MALE END PRIOR TO BREAKING OFF."
Patient problems: Feeding Problem
MAUDE report 24392658 ↗MalfunctionFeb 12, 2026Leak/Splash
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24326891 ↗InjuryFeb 12, 2026Leak/Splash
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."
Patient problems: Feeding Problem
MAUDE report 24324425 ↗MalfunctionFeb 12, 2026Fluid/Blood Leak
MalfunctionJan 27, 2026Material Integrity Problem
MalfunctionJan 19, 2026Material Integrity Problem
ENFIT CONNECTOR CRACKING AND LEAKING.
Patient problems: Insufficient Information
MAUDE report 24111760 ↗
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- Salem Sump 7771610ECardinal Health, Inc. · Gastrointestinal Tubes with Enteral Specific Connectors1 death18 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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