Medline ENFIT1000TCRecalls & reported problems
Medline Industries, Inc. · ENFIT SET TRANSITION CONNECTOR, MEDLINE · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884389196915), received between Nov 17, 2022 and Apr 5, 2023 — classified as 5 injuries.
The most frequently reported specific device problem is “Material Integrity Problem” (3 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.
Most reported problems
Device problems
- Material Integrity Problem3
- Appropriate Device Problem Term/Code Not Available1
- Break1
Patient problems
- Foreign Body In Patient4
- Feeding Problem1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryApr 5, 2023Break; Break
ACCORDING TO THE CUSTOMER, WHEN A PATIENT WAS RECEIVING A FEEDING THE RN NOTICED IT WAS "LEAKING" AND FOUND THE CONNECTOR HAD "BROKEN OFF INSIDE THE G-TUBE".
Patient problems: Foreign Body In Patient
MAUDE report 16682156 ↗InjuryMar 21, 2023Material Integrity Problem; Material Integrity Problem
ACCORDING TO THE FACILITY THE TUBE TIP BROKE DURING A FEEDING AND SOME OF THE PIECES WENT THROUGH THE PATIENT'S GI TRACT.
Patient problems: Foreign Body In Patient
MAUDE report 16580092 ↗InjuryJan 3, 2023Material Integrity Problem; Material Integrity Problem
ACCORDING TO THE FACILITY ON (B)(6) 2022 THE 'TRANSITION CONNECTOR BROKE OFF IN THE PATIENTS PEG TUBE AFTER A FEEDING CYCLE'.
Patient problems: Foreign Body In Patient
MAUDE report 16087052 ↗InjuryJan 3, 2023Material Integrity Problem; Material Integrity Problem
ACCORDING TO THE FACILITY ON (B)(6) 2022 THE 'TRANSITION CONNECTOR BROKE OFF IN THE PATIENT'S PEG TUBE AFTER A FEEDING CYCLE'.
Patient problems: Foreign Body In Patient
MAUDE report 16086799 ↗InjuryNov 17, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE CUSTOMER, ON (B)(6) 2022, THE PATIENT'S MOTHER DISCONNECTED THE FEEDING AFTER A CYCLE AND WHEN SHE WAS GOING TO START THE NEXT FEEDING CYCLE SHE NOTED AN 'OCCLUSION IN THE TUBE' THAT APPEARED TO BE 'PART OF THE ADAPTOR'.
Patient problems: Feeding Problem
MAUDE report 15821305 ↗
Other Enteral specific transition connectors devices
- Medline ENFIT1010GCMedline Industries, Inc. · Enteral specific transition connectors1 recall6 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.
How reports and recalls are matched · Editorial policy · Report an error on this page