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Kangaroo 8884705008E (UDI 30884521657612)Recalls & reported problems

Cardinal Health, Inc. · Y-Site Extension with ENFit Connection, 6" (15.2 cm) · Class 2

All models of Kangaroo (145)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
7
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 30884521657612), received between Sep 29, 2020 and Feb 12, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break4
  • Fluid/Blood Leak3

Patient problems

  • No Clinical Signs, Symptoms or Conditions4
  • No Consequences Or Impact To Patient2
  • Hypoglycemia1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 12, 2026Break

    THE CUSTOMER REPORTED FIVE OF THE TEN UNITS WERE USED, AND SEVERAL EITHER LEAKED OR SEPARATED AT THE TOP WHERE THE SYRINGE CONNECTS. LEAKING WAS OCCURRING FROM THE Y-SECTION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24322163 ↗
  • MalfunctionAug 19, 2025Break; Break

    THE CUSTOMER REPORTED THAT ONCE THEY BEGAN TO USE EACH EXTENSION SET, THEY WOULD EXPERIENCE LEAKAGE FROM THE Y-PORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22843792 ↗
  • MalfunctionMar 14, 2025Break; Break

    THE CUSTOMER REPORTED THE PORT CONNECTED TO THE KANGAROO FEEDING SETUP BROKE OFF DURING USE. ONCE BROKEN OFF OF EXTENSION, FEEDING WAS NOT ABLE TO BE DELIVERED UNTIL THE Y-CONNECTOR EXTENSION COULD BE REPLACED. THIS ALSO IMPACTED MEDICATION ADMINISTRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21605949 ↗
  • InjuryJun 3, 2024Break; Break

    CUSTOMER REPORTS: THE Y-SITE CONNECTOR WITH ENFIT CONNECTION FOR THE G/J TUBE BROKE. THE ENFIT CONNECTOR FELL OUT OF THE Y-SITE. THE CONNECTOR IS SUPPOSED TO BE SECURED IN PLACE WITH GLUE FROM MANUFACTURER. THE PATIENT RECEIVES TOTAL ENTERAL NUTRITION (TEN) OVERNIGHT WITH INSULIN COVERAGE PRIOR. THE INSULIN COVERAGE ADMINISTERED PER ORDER AND THE TEN STARTED AND LATER IT WAS OBSERVED THAT THE TEN WAS LEAKING FROM THE Y-SITE. THE PATIENT WITH SYMPTOMATIC HYPOGLYCEMIA TO 30'S (DIAPHORETIC). D50 WAS ADMINISTERED AND THE Y-SITE REPLACED, AND TEN RESTARTED. THE PROVIDER WAS MADE AWARE. THE BLOOD GLUCOSE RECOVERED; NO FURTHER INTERVENTION WAS REQUIRED. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2024 THE PATIENT¿S 30¿S BLOOD GLUCOSE LEVEL AND SUBSEQUENT TREATMENT OF ADMINISTERING THE D50 WAS A RESULT OF THE LEAKING/DISCONNECTED ENFIT CONNECTOR. THE PATIENT IS DIABETIC.

    Patient problems: Hypoglycemia

    MAUDE report 19454706 ↗
  • MalfunctionMay 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED LEAKING AT PROXIMAL END OF CONNECT SITE; BROKEN SETS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16888604 ↗
  • MalfunctionOct 28, 2020Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THAT THE EXTENSION SET TUBING IT IS LEAKING. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10750257 ↗
  • MalfunctionSep 29, 2020Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THAT FEED WAS LEAKING FROM THE EXTENSION SET TUBING. THE ISSUE WAS DISCOVERED WHEN THE EXTENSION SET WAS DONNED BEFORE GOING TO THE PATIENT'S ROOM.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10602732 ↗

Other Pump, Infusion, Enteral devices

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Sources and updates

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