Kangaroo 765559Recalls & reported problems
Cardinal Health, Inc. · Joey Safety Screw Spike Set,Anti-free Flow · Class 2
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884521155824), received between Jun 24, 2019 and Sep 14, 2021 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (13 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 Leak13
- Detachment of Device or Device Component1
- Infusion or Flow Problem1
- Material Separation1
Patient problems
- No Consequences Or Impact To Patient10
- Discomfort1
- Hypoglycemia1
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
- Urinary Retention1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2021Infusion or Flow Problem; Infusion or Flow Problem
THE CUSTOMER REPORTED A NEW TUBE FEED LINE WAS PRIMED AND ATTACHED TO A PATIENT FOR FEEDING. AFTER A FEW MINUTES OF RUNNING, THE PUMP BEGAN TO ALARM HOLD ERROR. AIR WAS NOTED IN THE LINE AND THEY ATTEMPTED TO PRIME THE LINE TO EXTRACT THE AIR BUT WERE UNABLE TO PRIME. THERE WAS NO HARM TO THE PATIENT,
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12468299 ↗MalfunctionNov 2, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE TUBE FEED WAS LEAKING FROM THE INSERTION PORT. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10771730 ↗MalfunctionOct 1, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED OUT OF THE CASE, THE CLIENT HAS HAD 15 SETS THAT WERE LEAKING AT THE CONNECTOR WHERE THE TUBE CONNECTS TO THE PUMP. THERE WAS NO PATIENT HARM.
Patient problems: Urinary Retention
MAUDE report 10612620 ↗MalfunctionMay 27, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THE DEVICES WERE LEAKING AT THE SPIKE CONNECTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10091778 ↗MalfunctionMay 19, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTS THAT THE ENTERAL FEEDING SET LEAKS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10070502 ↗MalfunctionMay 13, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTS THAT THE ENTERAL FEEDING SET LEAKS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10052665 ↗MalfunctionApr 14, 2020Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THERE WAS A COMPLETE DETACHMENT OF THE CLEAR TUBING FROM THE SAFETY SPIKE. THE STAFF TRIED TO REPAIR THE LEAK WITH WATERPROOF TAPE TO NO AVAIL. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9956923 ↗MalfunctionJan 22, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FEEDING SET WAS LEAKING A LOT WHILE THEY WERE ASLEEP AND THEY WOKE UP IN LOW BLOOD SUGAR DISCOMFORT. THEY TOOK THEIR DEX4 CAPSULES AND READ THEIR BLOOD SUGAR LEVELS REGULARLY AT HOME. NO OTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.
Patient problems: Discomfort; Hypoglycemia
MAUDE report 9617049 ↗MalfunctionJan 13, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FEEDING SET WAS DISCONNECTED AT THE SPIKE CONNECTION AND CAUSES LEAKING FROM THE SPIKE CONNECTOR. THE ISSUE WAS DISCOVERED PRIOR TO USE.
Patient problems: No Patient Involvement
MAUDE report 9581393 ↗MalfunctionNov 5, 2019Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
THE CUSTOMER REPORTED THERE WAS A LEAKAGE OF THE FEEDING TUBE AT THE CONNECTION OF THE TUBE TO THE PURPLE SCREW TIP. THE TUBING BECAME DISCONNECTED FROM THE PURPLE SCREW TIP RESULTING IN THE ENTIRE BAG OF THE FEED LEAKING ON THE FLOOR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9279545 ↗MalfunctionNov 1, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THE FLUSH BAG SPIKE SETS ARE LEAKING CONTINUOUSLY WITH SEVERAL HAVING TOTALLY EXPLODED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9265968 ↗MalfunctionJul 9, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE PUMP SET LEAKED AT THE PURPLE SPIKE CONNECTOR WHILE FEEDING THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8771142 ↗MalfunctionJun 24, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTS THEY HAD TWO SETS THAT LEAKED INTO THE PATIENT'S BACKPACK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8726805 ↗MalfunctionJun 24, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTS THEY HAD TWO SETS LEAKED INTO THE PATIENT'S BACKPACK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8726720 ↗
Other PUMP, INFUSION, ENTERAL devices
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- Kangaroo 382400Cardinal Health, Inc. · PUMP, INFUSION, ENTERAL677 reports
- Kangaroo 383400Cardinal Health, Inc. · Pump, Infusion, Enteral1 death659 reports
- Infinity Enteral Feeding Pump INFKIT2Zevex International, Inc. · Pump, Infusion, Enteral2 deaths407 reports
- Infinity Enteral Feeding Pump INFP01Zevex International, Inc. · Pump, Infusion, Enteral1 death207 reports
- Perfusor® 8713030UB. Braun Medical Inc. · Pump, infusion, enteral2 recalls3 deaths76 reports
- Kangaroo 775659Cardinal Health, Inc. · PUMP, INFUSION, ENTERAL1 death139 reports
- Perfusor® 8713031UB. Braun Medical Inc. · PUMP, INFUSION, ENTERAL1 recall21 deaths87 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.