Kangaroo 77000FDRecalls & reported problems
Cardinal Health, Inc. · Connect Safety Screw Spike Set,Anti-free Flow · Class 2
Quick summary
This Cardinal Health Kangaroo 77000FD Connect Safety Screw Spike Set is a disposable feeding set used with enteral infusion pumps to deliver liquid nutrition through a feeding tube. The 32 reports mostly describe liquid or blood leaking from the set, usually where the tubing meets the spike that screws into the feed bottle, and one report mentions air in the tubing. None of the reports describe death or injury, and 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
- 32
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10884521190818), received between Jun 26, 2018 and Aug 20, 2021 — classified as 32 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (30 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 Leak30
- Air/Gas in Device1
- Leak/Splash1
Patient problems
- No Consequences Or Impact To Patient24
- No Clinical Signs, Symptoms or Conditions6
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2021Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER REPORTS: THERE IS A LEAK AT THE JUNCTION OF THE SPIKE.
Patient problems: Insufficient Information
MAUDE report 12350696 ↗MalfunctionJun 10, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THE FEED LEAKS WHERE THE SPIKE OF THE FEEDING SET CONNECTS TO THE FEED BOTTLE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11978890 ↗MalfunctionMar 1, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE PATIENT'S FEEDING SETS WERE LEAKING BETWEEN THE TUBE AND THE PART THAT SCREWS INTO THE BAG. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11393548 ↗MalfunctionMar 1, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FEEDING SETS USED WITH THEIR CONNECT PUMP WERE LEAKING DUE TO THE PVC TUBING DISCONNECTING FROM THE CASSETTE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11393266 ↗MalfunctionDec 22, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THERE WAS A LEAK OBSERVED AT THE INTERFACE OF THE TUBE AND THE SPIKE CONNECTOR. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11060271 ↗MalfunctionDec 16, 2020Air/Gas in Device; Air/Gas in Device
THE PATIENT'S HUSBAND REPORTED THAT THERE WAS AIR IN THE TUBING BETWEEN THE BOTTLE AND THE PUMP DURING FEEDING. THE CUSTOMER CHANGED THE SET AND EVEN THOUGH THE DEBIT WAS SET TO 90ML/HR AND VOLUME AT 850ML, AFTER 6HR ONLY 225ML WAS ADMINISTERED (BASED ON THE AMOUNT LEFT IN THE BOTTLE). THE PATIENT IS FED OVERNIGHT (9PM-6:25AM) FOR A TOTAL OF 9H25MIN AT 90ML/HR AND A VOLUME OF 850ML. THE PATIENT IS FED TWOCAL HN B J-TUBE. THE PATIENT WAS NOT OVER/UNDER FED. THE FEEDING TOOK LONGER THE SECOND TIME THE SET WAS CHANGED BUT THE CUSTOMER DOES NOT REMEMBER HOW MUCH LONGER. THE SETS ARE CHANGED ON A DAILY BASIS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11016483 ↗MalfunctionDec 16, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE PATIENT'S HUSBAND REPORTED THAT THE TUBING SEPARATED FROM THE TIP DURING FEEDING AND THE FEEDING SET LEAKED. THE PATIENT IS FED OVERNIGHT (9PM-6:25AM) FOR A TOTAL OF 9H25 MINUTES AT 90ML/HR AND A VOLUME OF 850ML. THE PATIENT IS FED TWOCAL HN BY J-TUBE. THE PATIENT WAS NOT OVER/UNDERFED. THE SETS ARE CHANGED ON A DAILY BASIS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11016432 ↗MalfunctionOct 5, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THE PATIENT EXPERIENCED LEAKING AT THE CONNECTION OF THE TUBE AND SPIKE CONNECTOR DURING FEEDING. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10631334 ↗MalfunctionOct 5, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THE PATIENT EXPERIENCED LEAKING AT THE CONNECTION OF THE TUBE AND SPIKE CONNECTOR DURING FEEDING. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10631173 ↗MalfunctionAug 13, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THE KANGAROO CONNECT ENPLUS SPIKE SET WAS LEAKING WHERE THE TUBE MEETS THE PURPLE CONNECTOR. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10403318 ↗MalfunctionJul 30, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE TUBING LEAKED EVEN THOUGH IT WAS ATTACHED PROPERLY. THERE WAS PATIENT HARM REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10344942 ↗MalfunctionJul 7, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FEEDING SETS WERE LEAKING AND GETTING FEED ALL OVER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10238956 ↗MalfunctionMay 13, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FEEDING SET LEAKED WHERE THE TUBING APPARATUS FITS INTO THE BAG. THE PATIENT WAS DUCT TAPING THE CONNECTION TO AVOID LEAKING. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10052004 ↗MalfunctionMay 13, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FEEDING SET LEAKED WHERE THE TUBING APPARATUS FITS INTO THE BAG. THE PATIENT WAS DUCT TAPING THE CONNECTION TO AVOID LEAKING. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10051920 ↗MalfunctionMay 13, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FEEDING SETS LEAKED WHERE THE TUBING APPARATUS FITS INTO THE BAG. THE PATIENT WAS DUCT TAPING THE CONNECTION TO AVOID LEAKING. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10051847 ↗MalfunctionMay 13, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FEEDING SETS LEAKED WHERE THE TUBING APPARATUS FITS INTO THE BAG. THE PATIENT WAS DUCT TAPING THE CONNECTION TO AVOID LEAKING. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10051840 ↗MalfunctionMay 13, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FEEDING SET LEAKED WHERE THE TUBING APPARATUS FITS INTO THE BAG. THE PATIENT WAS DUCT TAPING THE CONNECTION TO AVOID LEAKING. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10051676 ↗MalfunctionMay 13, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FEEDING SET LEAKED WHERE THE TUBING APPARATUS FITS INTO THE BAG. THE PATIENT WAS DUCT TAPING THE CONNECTION TO AVOID LEAKING. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10051593 ↗MalfunctionMay 13, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FEEDING SET LEAKED WHERE THE TUBING APPARATUS FITS INTO THE BAG. THE PATIENT WAS DUCT TAPING THE CONNECTION TO AVOID LEAKING. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10051511 ↗MalfunctionMay 13, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FEEDING SET WAS LEAKING FROM WHERE THE TUBING APPARATUS FITS INTO THE BAG. THE PATIENT DUCT TAPED THE CONNECTION TO AVOID LEAKING. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10051261 ↗MalfunctionMay 12, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FEEDING SET LEAKED WHERE THE TUBING APPARATUS FITS INTO THE BAG. THE PATIENT WAS DUCT TAPING THE CONNECTION TO AVOID LEAKING. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10049242 ↗MalfunctionMay 12, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FEEDING SET LEAKED WHERE THE TUBING APPARATUS FITS INTO THE BAG. THE PATIENT WAS DUCT TAPING THE CONNECTION TO AVOID LEAKING. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10048102 ↗MalfunctionMay 7, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FEEDING SETS LEAKED WHERE THE TUBING APPARATUS FITS INTO THE BAG. THE PATIENT WAS DUCT TAPING THE CONNECTION TO AVOID LEAKING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10033964 ↗MalfunctionApr 28, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE ENTERAL FEEDING SET IS LEAKING AT THE CLEAR TUBING. THERE IS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10007385 ↗MalfunctionApr 28, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE ENTERAL FEEDING SET IS LEAKING AT THE CLEAR TUBING. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10007343 ↗
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.