NeoConnect Enteral Extension Set EXT-60YNCRecalls & reported problems
Neomed, Inc. · 60" Bifurcated Enteral Extension Set with ENFit Connector, Orange · Class 2
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00817584012035), received between Feb 12, 2020 and Feb 21, 2020 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak3
- Crack2
- Leak/Splash1
Patient problems
- No Known Impact Or Consequence To Patient5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2020Crack; Leak/Splash
TUBING REPORTED TO BE LEAKING AT THE FEMALE HUB, LOOKS LIKE A HAIRLINE FRACTURE. RECURRING PROBLEM WITH THIS PRODUCT AT THIS FACILITY FOR APPROXIMATELY 5 MONTHS. THE MANUFACTURER HAS BEEN NOTIFIED AND PRODUCT HAS BEEN RETURNED; THE MANUFACTURER SAYS THEY ARE INVESTIGATING. THE PROBLEM CONTINUES TO OCCUR. THERE ARE MULTIPLE REPORTS FOR THIS ISSUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9740407 ↗MalfunctionFeb 12, 2020Fluid/Blood Leak
LEAKING NOTED AT THE FEMALE HUB CONNECTOR, APPROXIMATELY HALF WAY THROUGH FEEDING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9699652 ↗MalfunctionFeb 12, 2020Fluid/Blood Leak
LEAKING NOTED AT THE FEMALE HUB CONNECTOR, APPROXIMATELY HALF WAY THROUGH FEEDING. RECURRING PROBLEM WITH THIS PRODUCT AT THIS FACILITY FOR APPROXIMATELY 5 MONTHS. THE MANUFACTURER HAS BEEN NOTIFIED AND PRODUCT HAS BEEN RETURNED; THE MANUFACTURER SAYS THEY ARE INVESTIGATING. THE PROBLEM CONTINUES TO OCCUR. THERE ARE MULTIPLE REPORTS FOR THIS ISSUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9699624 ↗MalfunctionFeb 12, 2020Fluid/Blood Leak
LEAKING NOTED AT THE FEMALE HUB CONNECTOR, APPROXIMATELY HALF WAY THROUGH FEEDING. RECURRING PROBLEM WITH THIS PRODUCT AT THIS FACILITY FOR APPROXIMATELY 5 MONTHS. THE MANUFACTURER HAS BEEN NOTIFIED AND PRODUCT HAS BEEN RETURNED; THE MANUFACTURER SAYS THEY ARE INVESTIGATING. THE PROBLEM CONTINUES TO OCCUR. THERE ARE MULTIPLE REPORTS FOR THIS ISSUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9699623 ↗MalfunctionFeb 12, 2020Crack
3 DIFFERENT FEEDING TUBE CONNECTORS CRACKED AT FEMALE HUB. RECURRING PROBLEM WITH THIS PRODUCT AT THIS FACILITY FOR APPROXIMATELY 5 MONTHS. THE MANUFACTURER HAS BEEN NOTIFIED AND PRODUCT HAS BEEN RETURNED; THE MANUFACTURER SAYS THEY ARE INVESTIGATING. THE PROBLEM CONTINUES TO OCCUR. THERE ARE MULTIPLE REPORTS FOR THIS ISSUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9699221 ↗
Other Tubes, Gastrointestinal (And Accessories) devices
- Bard® DigniShield® Stool Management System SMS002C. R. Bard, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 deaths525 reports
- CORTRAK* 2 ENTERAL ACCESS SYSTEM 20-0950Avanos Medical, Inc. · Tubes, gastrointestinal (and accessories)1 recall22 deaths134 reports
- Bard Tri-Funnel Replacement Gastrostomy Tube 000720Bard Access Systems, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 death170 reports
- EndoVive Safety PEG Kit M00566470Boston Scientific Corporation · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 recall1 death111 reports
- Kangaroo 8884711253Cardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)152 reports
- Kangaroo 8884711253ECardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)100 reports
- NutraGlide Nasal Feeding Tube ENFT-05055-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-06090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.