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Kangaroo 765100Recalls & reported problems

Cardinal Health, Inc. · Joey Safety Screw Spike with Flush Bag,Anti-free Flow · Class 2

Quick summary

This Kangaroo Joey feeding set connects a formula bag to an enteral pump. The 87 reports mostly describe formula leaking where the tubing meets the spike or port, with parts occasionally coming apart; no deaths or injuries were reported. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
87
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 20884521155784), received between May 15, 2019 and Sep 16, 2021 — classified as 87 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (86 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 Leak86
  • Detachment of Device or Device Component2
  • Leak/Splash1

Patient problems

  • No Consequences Or Impact To Patient57
  • No Known Impact Or Consequence To Patient13
  • No Clinical Signs, Symptoms or Conditions10
  • No Information4
  • No Patient Involvement2
  • Insufficient Information1

Recent adverse event reports

The 25 most recent of 87 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 16, 2021Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THAT LEAKAGE WAS NOTICED FROM THE JOIN BETWEEN THE PURPLE SPIKE AND THE HOSE. THE CUSTOMER STATED THAT THEY HAVE TO PUSH THE SET INTO THE PUMP (THE FIRST BIT BEFORE THE WIND STRETCHY PART), BUT THE OTHER SETS SIPPED IN NATURALLY. PER CUSTOMER THE LINES WERE NOT AS ROBUST/STRONGER IN GENERAL AND THE WHITE TRANSITION ADAPTERS WERE EXTREMELY HARD TO UNWIND. THERE WAS NO PATIENT HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12482795 ↗
  • MalfunctionAug 27, 2021Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THAT THE FEEDING SET WAS LEAKING AT THE TUBING INSERTION AREA INTO THE SPIKE END. THERE WAS NO PATIENT HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12378637 ↗
  • MalfunctionAug 25, 2021Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

    THE CUSTOMER REPORTED THE END USER REPORTED OVER THE PAST FEW MONTHS THE FEEDING SETS ARE COMING APART WHERE THE TUBE MEETS THE CONNECTOR CAUSING THE FORMULA TO LEAK. THERE WAS NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12365440 ↗
  • MalfunctionJul 29, 2021Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THAT THE JOEY FEEDING TUBE IS LEAKING AROUND THE PORT THAT ATTACHES TO THE FEEDING BAG. THERE WAS NO HARM TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12245810 ↗
  • MalfunctionJul 27, 2021Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THE JOEY FEEDING TUBE WAS LEAKING AT THE PORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12233440 ↗
  • MalfunctionJul 27, 2021Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THE JOEY FEEDING TUBES ARE LEAKING AT THE PORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12233282 ↗
  • MalfunctionJun 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THE FEEDING SETS ARE LEAKING. THERE WAS NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11932412 ↗
  • MalfunctionJun 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THE FEEDING SETS ARE LEAKING. THERE WAS NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11932130 ↗
  • MalfunctionMay 14, 2021Fluid/Blood Leak; Fluid/Blood Leak

    CUSTOMER REPORTS: THE TUBING THAT IS ATTACHED TO THE BAG COMES OUT ONCE LIQUID IS IN THE TUBING.

    Patient problems: Insufficient Information

    MAUDE report 11825778 ↗
  • MalfunctionFeb 15, 2021Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED BEEN HAVING ISSUES WITH THE FEEDING SETS LEAKING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11330467 ↗
  • MalfunctionDec 22, 2020Fluid/Blood Leak; Fluid/Blood Leak

    THE DISTRIBUTOR REPORTED THAT A HOME PATIENT EXPERIENCED ISSUES WITH THE FEEDING BAGS LEAKING. THERE WAS NO HARM TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11057071 ↗
  • MalfunctionNov 16, 2020Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THE FEEDING SETS WERE LEAKING WHERE THE TUBE MEETS THE CONNECTOR. THERE WAS NO HARM TO THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10842704 ↗
  • MalfunctionNov 16, 2020Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THE FEEDING SETS WERE LEAKING WHERE THE TUBE MEETS THE CONNECTOR. THERE WAS NO HARM TO THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10842656 ↗
  • MalfunctionOct 8, 2020Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED, DURING BEDSIDE ROUNDS THEY NOTICED THE FEED LEAKED FROM WHERE THE TUBE ATTACHES TO THE DEVICE. IT WAS REPLACED IMMEDIATELY. THERE WAS NO HARM TO THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10649776 ↗
  • MalfunctionOct 8, 2020Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THAT THE FEEDING SET PRESENTED A NUTRITION LEAKAGE IN THE SPIKE CONNECTION. THE EVENT OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT THEREFORE NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTIONS WERE ASSOCIATED WITH THIS EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10649539 ↗
  • MalfunctionOct 8, 2020Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THAT WHILE ATTACHING A NEW FEEDING SET, THE ENTIRE TUBE DISCONNECTED FROM THE SPIKE AS SOON AS THE BAG WAS HUNG AND FORMULA WAS POURING OUT. THE SET WAS IMMEDIATELY REMOVED AND REPLACED. THERE WAS NO PATIENT HARM.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10649164 ↗
  • MalfunctionSep 24, 2020Fluid/Blood Leak; Fluid/Blood Leak

    CUSTOMER REPORTS: THE JOEY ENPLUS SPIKE WITH FLUSH BAG IS LEAKING.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10583333 ↗
  • MalfunctionSep 2, 2020Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THAT THE FEEDING SETS ARE LEAKING AT THE SPIKE CONNECTION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10485846 ↗
  • MalfunctionSep 2, 2020Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THAT THE FEEDING SETS ARE LEAKING AT THE SPIKE CONNECTION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10485769 ↗
  • MalfunctionSep 2, 2020Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THAT THE FEEDING SETS ARE LEAKING AT THE SPIKE CONNECTION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10485720 ↗
  • MalfunctionAug 19, 2020Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THAT THE FEEDING SETS ARE LEAKING AT THE SPIKE CONNECTION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10428890 ↗
  • MalfunctionAug 19, 2020Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

    THE CUSTOMER REPORTED THE PURPLE CAP BROKE FROM THE TUBING CAUSING THE FORMULA TO LEAK. THERE WAS NO PATIENT HARM.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10425685 ↗
  • MalfunctionAug 18, 2020Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THE BASE OF THE FEEDING BAG LEAKS. THERE WAS NO PATIENT HARM.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10420657 ↗
  • MalfunctionAug 18, 2020Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THE DEVICE LEAKS FROM THE BASE OF THE BAG. THERE WAS NO PATIENT HARM.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10420506 ↗
  • MalfunctionAug 17, 2020Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THAT THE ENTERAL FEEDING SETS LEAKED FROM THE BASE OF THE BAG WHICH CAUSED A LOSS OF FORMULA. THERE WAS NO PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10414302 ↗

Other PUMP, INFUSION, ENTERAL devices

All PUMP, INFUSION, ENTERAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.