Kangaroo 8884721055ERecalls & reported problems
Cardinal Health, Inc. · Feeding Tube · Class 2
- Adverse event reports
- 9
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521582989), received between Nov 7, 2019 and Jul 1, 2024 — classified as 1 death, 1 injury, 7 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove4
- Break2
- Detachment of Device or Device Component2
- Complete Blockage1
- Component Missing1
- Material Separation1
- Obstruction of Flow1
Patient problems
- No Consequences Or Impact To Patient4
- No Clinical Signs, Symptoms or Conditions2
- Dyspnea1
- No Known Impact Or Consequence To Patient1
- Unspecified Respiratory Problem1
- Vomiting1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryJul 1, 2024Break; Break
THE CUSTOMER REPORTED A BURST TUBE. THE TUBE WAS INSERTED ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON JUNE 21, 2024, STATED THAT THE BURST OCCURRED NEAR THE 50CM MARKER ON THE TUBE, CLOSER TO THE PURPLE Y PORT END. THERE WERE NO PIECES LEFT IN THE PATIENT, IT APPEARED TO HAVE JUST RUPTURED BUT THE ENTIRE TUBE WAS INTACT. THE PATIENT HAD RESPIRATORY DISTRESS, REQUIRED SUCTIONING (BOTH ORALLY AND DEEP), VOMITED, AND REQUIRED OXYGEN BY NASAL CANULA. THE PATIENT DID NOT REQUIRE ADDITIONAL MEDICAL INTERVENTION TO REMOVE THE TUBE, THE TAPE SECURING THE TUBE WAS REMOVED AND THE TUBE WAS REMOVED WITHOUT ISSUE. AT THIS POINT THE PATIENT HAS RECOVERED, A NEW TUBE WAS INSERTED, AND NG FEEDS RESTARTED. THE PATIENT REQUIRED OXYGEN FOR APPROXIMATELY 48 HOURS.
Patient problems: Dyspnea; Vomiting
MAUDE report 19643307 ↗DeathJun 4, 2024Break; Break
PER ADDITIONAL INFORMATION RECEIVED, THE CAUSE OF DEATH WAS SEPSIS AND THIS WAS RELATED TO THE PATIENTS CO-MORBID CONDITIONS/MEDICAL HISTORY. THE CUSTOMER WAS ALSO ASKED THE FOLLOWING IF THEY BELIEVE THERE WAS A DIRECT CORRELATION BETWEEN THE CARDINAL HEALTH DEVICE AND THE PATIENT¿S DEATH AND THEY RESPONDED "YES. PATIENT¿S RAPID RESPIRATORY DECOMPENSATION AND SUBSEQUENT INTUBATION WERE DIRECTLY RELATED TO ASPIRATING ORAL CONTRAST THAT WAS GIVEN THROUGH THE DHT". BASED ON THIS INFORMATION, THE US REGULATORY REPORT WILL BE REVISED FROM A SERIOUS INJURY TO A DEATH.
Patient problems: Unspecified Respiratory Problem
MAUDE report 19461203 ↗MalfunctionApr 14, 2022Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component
THE CUSTOMER REPORTED WHILE IN THE OR, THE TUBE WAS PLACED BY HAND. THE STYLET WAS NOT ABLE TO BE RETRACTED. THE TUBE WAS FLUSHED AGAIN AND STILL IT WOULD NOT RETRACT. ADDITIONAL FORCE WAS APPLIED AND THE CAP TORN OFF LEAVING EXPOSED WIRE. THERE WAS NO OPTION BUT TO REMOVE THE TUBE AND REPLACE IT. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14112918 ↗MalfunctionApr 1, 2022Complete Blockage; Complete Blockage
THE CUSTOMER REPORTED THAT THE PATIENT HAD AN ENFIT DOBHOFF TUBE AND WAS RECEIVING TOTAL ENTERAL NUTRITION (TEN) THE TEN KANGAROO PUMP ALARMED FOR A CLOGGING ERROR DOWNSTREAM OF THE PUMP. THEY HELD THE TEN AND ATTEMPTED TO FLUSH THE DOBHOFF TUBE WITH STERILE WATER AND WAS MET WITH HARD RESISTANCE AND WAS UNABLE TO FLUSH. THE STERILE WATER APPEARED TO LEAK OUT THE OTHER PORT WHILE TRYING TO FLUSH. THE DOBHOFF TUBE WAS DISCONTINUED AND REPLACED IN THE MORNING SINCE THERE WAS NOT A PROVIDER WORKING OVERNIGHT TRAINED IN DOBHOFF TUBE INSERTION. THE PATIENT MISSED APPROXIMATELY 8 HOURS OF ENTERAL NUTRITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13979056 ↗MalfunctionNov 2, 2020Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component
THE CUSTOMER REPORTED A PATIENT CAME OUT OF THE OR WITH A DOBHOFF SUTURED TO HIS LEFT NARE. AN X-RAY WAS PERFORMED TO CONFIRM PLACEMENT AND SHOWED THE TUBE NEEDED TO BE ADVANCED. THE TUBE WAS ADVANCED BY THE COVERING PROVIDER AND WHEN SHE ATTEMPTED TO REMOVE THE WIRE, SHE WAS UNABLE TO DO SO. THE CAP THAT HELD THE WIRE CAME OFF AND SHE ATTEMPTED TO REMOVE THE WIRE WITH HEMOSTATS COULD NOT. A NEW DOBHOFF WAS PLACED WITHOUT DIFFICULTY. THE TIP OF THE DIFFICULT DOBHOFF LOOKED SLIGHTLY DIFFERENT THAN THE ONE THAT HAD THE WIRE THAT PULLED OUT EASILY. JUST FOR COMPARISON, THE PROVIDER TRIED TO PULL THE WIRE FROM ANOTHER DOBHOFF FRESH FROM THE PACKAGE AND FOUND THE WIRE QUITE DIFFICULT TO REMOVE. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10774858 ↗MalfunctionAug 12, 2020Obstruction of Flow; Obstruction of Flow
THE CUSTOMER REPORTED THE EN FIT TUBING WAS BLOCKED AT THE Y CONNECTOR. THE HEALTH CARE PROVIDER ATTEMPTED TO UNCLOG IT, RE-POSITIONED IT, AND IT WAS STILL BLOCKED. THE TUBE WAS REPLACED AND THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10396685 ↗MalfunctionNov 26, 2019Difficult to Remove; Difficult to Remove
THE CUSTOMER REPORTED THE STYLET DID NOT HAVE A CAP SO THE NURSE HAD TO TWIST THE STYLET AROUND HER FINGER TO PULL IT OUT OF THE NASOGASTRIC TUBE. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9378397 ↗MalfunctionNov 19, 2019Difficult to Remove; Component Missing; Difficult to Remove; Component Missing
THE CUSTOMER REPORTED THE STYLET HAT NEEDED TO BE REMOVED FROM THE NGT BUT IT DID NOT HAVE A CAP. THE RN HAD TO TWIST IT AROUND THEIR FINGER TO PULL OUT THE STYLET. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9342686 ↗MalfunctionNov 7, 2019Material Separation; Material Separation
THE CUSTOMER REPORTED THAT THE NASAL TUBE WAS DISLOCATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9290797 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.