Kangaroo 461055E (UDI 20884521742205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 20884521742205), received between Sep 23, 2020 and Jun 7, 2023 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  THE CUSTOMER REPORTED AFTER TWO DAYS OF USE, THE PORT DISCONNECTED FROM THE RUBBER Y IT ATTACHES TO. THE Y WAS LEAKING WHERE IT CONNECTS TO THE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17078332 ↗
• MalfunctionJan 24, 2023Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED THAT NASOENTERIC TUBE CLOGGED FOLLOWING MEDICATION ADMINISTRATION. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16236171 ↗
• MalfunctionJan 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE PORT DISCONNECTED FROM THE TUBE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16234914 ↗
• MalfunctionDec 14, 2022Material Twisted/Bent; Material Twisted/Bent

  THE CUSTOMER REPORTED THAT THE IRIS FEEDING TUBE GOT STUCK IN THEIR PATIENT'S NASAL CAVITY UPON REMOVAL OF THE DEVICE. THE NURSE WAS ABLE TO INSERT THE FEEDING TUBE THROUGH THE PATIENT'S NOSE AND DOWN TO THEIR STOMACH WITHOUT ISSUE. AN X-RAY WAS ORDERED AND DETERMINED THAT THE TUBE WAS COILED IN THE PATIENT'S STOMACH. INSTEAD OF ONLY RETRACTING A SMALL PORTION OF THE TUBE TO REMOVE THE COIL, FOR SOME REASON, THE NURSE ATTEMPTED TO RETRACT THE TUBE COMPLETELY OUT OF THE PATIENT'S NOSE. WHEN THE DISTAL TIP OF THE TUBE ENTERED BACK THROUGH THE PATIENT'S NASAL PASSAGE, IT BECAME STUCK. IT WAS EVIDENT THAT THE NASAL PASSAGE HAD SWOLLEN SHUT FROM THE BEGINNING OF THE PROCEDURE AND THE TIP OF THE FEEDING TUBE WOULD NOT BE ABLE TO RETRACT THROUGH THE NOSE. THE NURSING STAFF HAD TO ENGAGE AN ANESTHESIOLOGIST AND OTHER STAFF TO RETRACT THE TUBE OUT OF THE PATIENT'S MOUTH WITH FORCEPS, CUT THE TIP OF THE TUBE, THEN FULLY RETRACT THE TUBE THROUGH THE NARROW PASSAGEWAY IN THE PATIENT'S NOSE. PER CUSTOMER, THE SIZE OF THE TIP OF THE IRIS FEEDING TUBE IS BEING BLAMED AS THE REASON FOR THIS PRODUCT COMPLAINT. THE TIP OF THE TUBE IS TOO LARGE TO EASILY RETRACT THROUGH THE NASAL PASSAGEWAY WHICH PRE

  Patient problems: Discomfort; Swelling/ Edema

  MAUDE report 15982410 ↗
• MalfunctionNov 7, 2022Break; Fluid/Blood Leak; Obstruction of Flow; Material Twisted/Bent; Break; Fluid/Blood Leak; Obstruction of Flow; Material Twisted/Bent

  THE CUSTOMER REPORTED THAT THE NASAL JEJUNAL TUBE WAS PLACED WITHOUT DIFFICULTY. THE WIRE WAS LEFT IN PLACE FOR RN TO REMOVE POST X-RAY. X-RAY WAS OBTAINED IN PROPER POSITION WITHOUT EVIDENCE OF KINK. AT APPROXIMATELY 1840 #1 INFORMED THAT THE LINE WAS KINKED. ALSO, #1 NOTED A SMALL CRACK IN THE TUBE WHERE FLUID WAS DRIPPING OUT ON THE PROXIMAL END OF THE TUBE. A NEW TUBE IS BEING PLACED. ON REMOVAL, CLOG WAS STILL NOTED. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15743009 ↗
• MalfunctionJul 28, 2022Detachment of Device or Device Component; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REPORTED THE 2ND PORT ON THE TUBE HAD A STRANGE OPENING, AND DID NOT LOOK NORMAL. THE TUBE WAS STILL USED IN THE PATIENT. ADDITIONAL INFORMATION RECEIVED STATED THE ENFIT CONNECTOR DETACHES FROM THE Y PORT.

  Patient problems: Insufficient Information

  MAUDE report 15121377 ↗
• MalfunctionMay 31, 2022Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED THAT THE PATIENT'S IRIS NASOENTERIC TUBE CLOGGED. ALL ATTEMPTS TO DISLODGE THE CLOG WERE UNSUCCESSFUL. A NEW TUBE HAD TO BE PLACED. THE TUBE WAS PLACED ABOUT TWO WEEKS AGO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14549213 ↗
• MalfunctionMar 4, 2022Crack; Crack

  THE CUSTOMER REPORTED THAT THE FEEDING TUBE WAS CRACKED. PER ADDITIONAL INFORMATION RECEIVED, THE SAMPLE WAS REMOVED FROM THE PATIENT AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13667352 ↗
• MalfunctionFeb 16, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER STATES THAT THE IRIS TUBE HAD A TUBE TEAR IN THE SOFT RUBBER V PURPLE PORTION OF THE FEEDING TUBE BETWEEN THE TWO CONNECTORS. THERE WAS NO HARM REPORTED. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS TUBE FEEDING LEAKING FROM THE SITE. AFTER TALKING TO THE NURSE, THE CUSTOMER FOUND OUT THAT THE DALE CONNECTOR WAS VERY TIGHT ON THE TUBE. THEY WERE WONDERING IF WHEN PLACING THE CONNECTOR, THE NURSE MAY HAVE INADVERTENTLY TORN THE TUBE. THE MATERIAL OF THE TUBE IS SOFTER IN THAT AREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13541896 ↗
• MalfunctionJan 31, 2022Crack; Crack

  THE CUSTOMER STATED THE INSERTION WAS UNCOMPLICATED. DAYS LATER THE PRIMARY RN NOTICED THE TUBE WAS LEAKING FROM THE HUB. ON ASSESSMENT THE HUB WAS SPLIT IN THE MIDDLE BETWEEN THE PORTS. THE TUBE WAS FLUSHED WITH WATER AND WAS LEAKING FROM THE SPLIT. THE FEEDING TUBE WAS REMOVED AND ANOTHER WAS PLACED AT BEDSIDE WITHOUT DIFFICULTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13392635 ↗
• MalfunctionDec 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT AFTER MULTIPLE CONNECTIONS/DISCONNECTIONS, THE RUBBER Y PORTION BEGAN TO TEAR AND LEAKS. PER ADDITIONAL INFORMATION RECEIVED, THE TUBE WAS REPLACED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13118597 ↗
• MalfunctionNov 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT ONE OF THE FEEDING PORTS ON THE PATIENT¿S DUOTUBE BROKE OFF DURING FEEDING, SO THE TUBE HAD TO BE REMOVED AND REPLACED. THE TUBE WAS PLACED ON (B)(6) 2021 AND THE BREAK OCCURRED ON (B)(6) 2021. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE PURPLE PORT WAS DETACHED, AND IT WAS UNKNOWN IF THERE WAS ANY LEAK OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12848659 ↗
• MalfunctionAug 27, 2021Fluid/Blood Leak; Obstruction of Flow; Fluid/Blood Leak; Obstruction of Flow

  THE CUSTOMER REPORTED THE TUBE CLOGGED AND THE SEAL AROUND THE PORT LEAKED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12377563 ↗
• MalfunctionJun 4, 2021Break; Break

  THE CUSTOMER REPORTED THAT THE FEEDING TUBE WAS SEVERED SOMEHOW, NO ONE KNOWS HOW. THE FEEDING TUBE WAS CLAMPED OFF WITH HEMOSTATS ONLY TO STOP THE LEAK. ADDITIONAL INFORMATION PROVIDED STATED THAT THE DEVICE WAS SEVERED JUST BELOW THE GREY Y PORTS. IT WAS COMPLETELY SEPARATED IN TWO DIFFERENT PIECES. IT IS NOT KNOWN HOW LONG THE DEVICE WAS IN USE PRIOR TO THE INCIDENT. THE DEVICE WAS FOUND TO BE SEVERED WHEN STAFF WAS ATTEMPTING TO TRANSFER THE PATIENT BACK TO THEIR BED. NO PATIENT INJURY ALTHOUGH THE PATIENT NOTED THERE WAS A TUG AND HE DIDN¿T KNOW WHAT HAPPENED. THE DEVICE WAS REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11941030 ↗
• MalfunctionMay 27, 2021Material Twisted/Bent; Material Twisted/Bent

  THE CUSTOMER REPORTED THAT THE TUBE HAD TO BE REMOVED BECAUSE IT WAS KINKED. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER ON JUNE 04, 2021 STATED THAT THE TUBE WAS IN USE FOR 6 WEEKS. IT WAS INITIALLY POST-PYLORIC BUT IT MOVED BACK INTO THE STOMACH. THE PROVIDER ATTEMPTED TO REINSERT THE STYLET TO ADVANCE BUT COULD ONLY GET IT IN 60% OF THE WAY. SHE THOUGHT IT WAS KINKED BUT WAS NOT ABLE TO CONFIRM THAT WITH AN X-RAY. THE TUBE WAS PATENT AS SHE WAS ABLE TO FLUSH IT. IT WAS DEEMED TO BE KINKED SO SHE PULLED IT AND REPLACED IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11895073 ↗
• MalfunctionMay 14, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE PORT CRACKED AND NEEDED TO BE REPLACED. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2021 STATED THAT THE FEEDING TUBE LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11829232 ↗
• MalfunctionMay 14, 2021No Flow; No Flow

  THE CUSTOMER REPORTED THAT THE PATIENT WAS ON CONTINUOUS FEED, THE FEEDING WAS PAUSED OVERNIGHT AND UPON RESUMING IT APPEARED TO BE CLOGGED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11826547 ↗
• MalfunctionMay 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE PORT BROKE OFF AND THE TUBE NEEDED TO BE REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11778277 ↗
• MalfunctionApr 30, 2021Obstruction of Flow; Obstruction of Flow

  CUSTOMER REPORTS; LESS THAN 48 HOURS AFTER PLACEMENT, THE TUBE CLOGGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11752684 ↗
• MalfunctionApr 28, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE ENDS (Y-PORT) OF THE IRIS FEEDING TUBES KEEP BREAKING. SOME TUBES ARE ONLY LASTING 2 DAYS AFTER PLACEMENT INTO THE PATIENT. THE CUSTOMER BELIEVES THIS IS DUE TO THE WIRE INSIDE THE TUBE NOT FITTING WITH THE PEG ENDS AND SUBSEQUENTLY LEAKING. NO PATIENT INJURY WAS REPORTED. NEW INFORMATION RECEIVED FROM THE INITIAL REPORTER ON (B)(6) 2021 STATED THAT THE Y-PORT AT THE END OF THE TUBES SPLIT IN THE PURPLE SECTION BETWEEN THE TWO PORTS. THIS MEANS THE TUBES LEAK, AND CAN NOT BE USED. THIS SEEMS TO HAPPEN AFTER 1-2 WEEKS OF USE. THIS IS HAPPENING WITH A LOT OF TUBES, TO AVOID HAVING TO REPLACE THE WHOLE TUBE, THEY HAVE CUT THE END OF THE TUBE OFF AND INSERTED A STANDARD REPLACEMENT PEG END. THIS ALLOWS THEM TO CONTINUE USING THE TUBE. HOWEVER THE PEG ENDS NEED REPOSITIONING EVERY SO OFTEN (CUTTING OFF A FURTHER 1-2CM OF TUBE AND REATTACHING THE PEG END), AND THEY THINK THIS IS BECAUSE THE TUBE CAN NOT MOLD PROPERLY TO THE PEG END DUE TO THE INTERNAL WIRE (THAT POWERS THE CAMERA ON THE TIP). THIS WIRE MEANS THE INTERNAL DIAMETER OF THE TUBE IS NOT COMPLETELY CIRCULAR, RENDERING THE CONNECTION LIABLE TO LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11738214 ↗
• MalfunctionFeb 24, 2021Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE IRIS FEEDING TUBE HAS A PORT THAT CAN BECOME DISCONNECTED WHEN IN USE. THERE IS NO WAY TO SECURE THE PORT (IT IS UNDER A LUER LOCK), THUS TUBE FEEDING SOLUTION CAN END UP NOT INFUSING INTO THE PATIENT. ONCE THIS PORT BECOMES DISCONNECTED, THE PUMP WILL CONTINUE TO PUMP FORMULA ALL OVER THE PATIENT AND THE FLOOR. NURSES HAVE TRIED TO TAPE THE PORT SHUT TO KEEP IT FROM SPILLING BUT IT DOES NOT SECURE THE TUBING CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11376229 ↗
• MalfunctionSep 23, 2020Difficult to Remove; Difficult to Remove

  DURING A VISIT TO THE FACILITY, THE SALES REPRESENTATIVE OBSERVED AN IRIS PLACEMENT. THE FEEDING TUBE WAS PLACED BY NURSE (B)(6). UPON CONFIRMATION VIA A KUB, THE NURSE WAS UNABLE TO REMOVE THE STYLET. EVEN AFTER THE REMOVAL OF THE FEEDING TUBE THE STYLET STILL COULD NOT BE REMOVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10574995 ↗