Medline Industries ENFIT70552Recalls & reported problems
Medline Industries, Inc. · SET,PUMP,1000ML BAG,ENFIT,MEDLINE · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884389190333), received between May 14, 2019 and Sep 30, 2026 — classified as 3 injuries, 10 malfunctions.
The most frequently reported specific device problem is “Break” (7 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
- Break7
- Crack3
- Leak/Splash3
- Obstruction of Flow2
- Detachment of Device or Device Component1
- Entrapment of Device1
- Fluid/Blood Leak1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Feeding Problem1
- Foreign Body In Patient1
- Hypoglycemia1
- Insufficient Information1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break
It was reported that "THE ISSUE IS WITH THE ENFIT PORTION, ENFIT TWIST CONNECTOR" and "THE ENFIT PIECE HAS BEEN SHATTERING CAUSING PIECES TO BE STUCK IN THE END OF THE EXTENSION TUBING OR JUST LEAKING."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946757 ↗MalfunctionSep 24, 2026Break; No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884867 ↗MalfunctionSep 18, 2026Crack; Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820319 ↗MalfunctionJun 5, 2026Break
IT WAS REPORTED THAT THE CONNECTING PIECE BETWEEN THE BAG AND THE CATHETER IS BREAKING INSIDE OF THE CATHETER.
Patient problems: Insufficient Information
MAUDE report 25410048 ↗InjurySep 10, 2025Material Fragmentation; Leak/Splash; Melted; Material Fragmentation; Leak/Splash; Melted
ACCORDING TO THE FACILITY, ON (B)(6) 2025, "TUBE FEED BAG WAS CONNECTED TO G -TUBE. IT WAS LEAKING NOT LONG AFTER CONNECTION AND WHEN DISCONNECTED IT WAS NOTICED TO HAVE CRACKED AND MELTED INTO THE G - TUBE, CAUSING A PATIENT TO HAVE TO RECEIVE INTERVENTION AND HIS G -TUBE EMERGENTLY REPLACED. PER THE FACILITY, "BITS OF PLASTIC THAT CRACKED OFF FROM TUBE FEED CONNECTOR" GOT INSIDE THE PATIENT. "PATIENT IS DOING WELL."
Patient problems: Foreign Body In Patient
MAUDE report 23015853 ↗InjuryJun 12, 2024Leak/Splash; Leak/Splash
ACCORDING TO THE FACILITY ON 04/08/24 THERE WAS AN ISSUE "AT THE CONNECTION SITE WHERE IT SCREWS INTO EXTENSION TUBING" CAUSING THE FEEDING TO LEAK.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19519754 ↗MalfunctionApr 12, 2023Obstruction of Flow
MEDLINE, ENTRAFLOW DOES NOT FLOW AFTER PRIMING. CHAMBER FILLS AND WILL NOT DRIP. THE STAFF TRIED TROUBLE-SHOOTING BY MANUALLY FILLING AND CLEARING THE SYSTEM. IT CONTINUES TO BEEP AND DISPLAYS "OCCLUSION". MANUFACTURER RESPONSE FOR TUBES, GASTROINTESTINAL (AND ACCESSORIES), MEDLINE INDUSTRIES (PER SITE REPORTER) WILL OBTAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16723954 ↗MalfunctionAug 3, 2021Break; Detachment of Device or Device Component
IT WAS REPORTED THAT A PIECE OF THE FEEDING PUMP CONNECTOR'S TIP BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12269663 ↗MalfunctionJul 28, 2021Break
IT WAS REPORTED THAT A PIECE OF THE TIP OF THE ENFIT PUMP SET CONNECTOR WAS FOUND TO HAVE BROKEN OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12238795 ↗MalfunctionJul 28, 2021Break
IT WAS REPORTED THAT A PIECE OF THE TIP OF THE ENFIT PUMP SET CONNECTOR WAS FOUND TO HAVE BROKEN OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12238668 ↗MalfunctionApr 7, 2021Break; Crack; Entrapment of Device
IT WAS REPORTED, "THE TIP ON THE PURPLE ADAPTERS ARE CRACKING AND BREAKING WHILE IN THE CONNECTOR." ONE TIP PIECE CRACKED AND MADE ITS WAY INTO THE G-TUBE. G-TUBE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11628263 ↗MalfunctionJun 29, 2020Crack; Obstruction of Flow
IT WAS REPORTED THE FEEDING BAG CRACK AND PIECES GOT STUCK IN THE GTT, WHICH STOPPED MEDICATION AND FEEDINGS.
Patient problems: Feeding Problem
MAUDE report 10205647 ↗InjuryMay 14, 2019Leak/Splash
IT WAS REPORTED THAT THE FEEDING SET WAS LEAKING AND PATIENT REQUIRED TREATMENT FOR HYPOGLYCEMIA.
Patient problems: Hypoglycemia
MAUDE report 8607683 ↗
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- Kangaroo 8884711253Cardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)152 reports
- NutraGlide Nasal Feeding Tube ENFT-06090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-05090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- Kangaroo 8884711253ECardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)100 reports
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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