Kangaroo 461043E (UDI 20884521742199)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 20884521742199), received between Jul 29, 2020 and Aug 3, 2022 — classified as 2 deaths, 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• DeathAug 3, 2022Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT THE PATIENT HAD AN IRIS TUBE PLACED INTO THE LUNG RESULTING IN A PNEUMOTHORAX. THE RN REMOVED THE FEEDING TUBE AND TRIED TO PLACE THE TUBE AGAIN. THE PATIENT DIED FROM THE INJURY.

  Patient problems: Pneumothorax

  MAUDE report 15160266 ↗
• DeathMar 24, 2022Use of Device Problem; No Apparent Adverse Event; Use of Device Problem; No Apparent Adverse Event

  THE CUSTOMER REPORTED THE IRIS TUBING WAS MISPLACED IN THE AIRWAY DUE TO HEAVY SECRETION. THEY COULD NOT CONFIRM VIA VISUALIZATION. THE RADIOLOGIST AND STAFF VIA FLURO MISSED MISPLACED TUBE DUE TO OTHER OG (ORAL GASTRIC) TUBE PLACED IN STOMACH. MEDICATION/NUTRITION WAS ADMINISTERED. ADDITIONAL INFORMATION RECEIVED STATED THE PATIENT PASSED AWAY BUT AT THIS TIME IT IS UNKNOWN IF THE DEVICE WAS RELATED TO THE PATIENT¿S DEATH.

  Patient problems: Insufficient Information

  MAUDE report 13893216 ↗
• MalfunctionOct 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE FEEDING SET GOT STUCK ON THE ENFIT PORT OF THE KANGAROO IRIS TUBE. THE ENFIT PORT BROKE AROUND THE CONNECTION PORT RESULTING IN THE NURSE HAVING TO PULL THE TUBE AND REPLACE IT ALONG WITH THE FEEDING SET. THE PORT MAY HAVE BROKE AS A RESULT OF OVERTIGHTENING DURING THE NIGHT SHIFT. PER ADDITIONAL INFORMATION RECEIVED, THE CUSTOMER STATED THAT THE PORT CRACKED AND THEN LATER DETACHED AFTER THE NURSE TRIED TO DISCONNECT THE FEEDING SET FROM THE ENFIT PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12689212 ↗
• MalfunctionOct 21, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THE BEDSIDE NURSE OVERTIGHTENED THE KANGAROO FEEDING SET INTO THE KANGAROO IRIS ENFIT PORT. THE BEDSIDE NURSE COULD NOT DISCONNECT THE FEEDING SET AND AS A RESULT NEEDED TO PULL THE KANGAROO IRIS TUBE OUT AND REPLACE. WHEN THE NURSE, PULLED THE ORIGINAL IRIS TUBE OUT, THE SALES REP, WAS PREPARING THE IRIS CONSOLE FOR THE NEW TUBE PLACEMENT, AND ANOTHER NURSE, WAS ALSO IN THE ROOM SUPPORTING. AFTER THE NURSE PULLED THE ORIGINAL TUBE OUT, HE NOTICED THE TUBE DID NOT LOOK RIGHT AT THE END OF THE IRIS TUBE. THE SALES REP TURNED HIS ATTENTION FROM THE CONSOLE TO THE PULLED IRIS TUBE AND NOTICED THE SLEEVE WHERE THE IRIS CAMERA ATTACHES TO THE TUBE WAS LOOSE AND SHOWING THE WIRES THAT WOULD BE PRESUMED TO ATTACH TO THE CAMERA. THE CAMERA WAS STILL ATTACHED TO THE TUBE, BUT WAS LOOSE. THE PATIENT IS SAFE AND WAS NOT HARMED. A NEW IRIS TUBE WAS SUCCESSFULLY AND SAFELY PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12672644 ↗
• MalfunctionJul 20, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE ONE OF THE TWO LUER LOCK PORT BROKE, CAUSES LEAKING AND ISSUES WITH NG TUBE. PER CUSTOMER, THE OTHER VALVE WAS NOT BROKEN BUT UNABLE TO GIVE FEEDINGS WITH OTHER BROKEN PORT DUE TO LOSS IN PRESSURE. WHEN ATTACHING THE TUBE FEEDING TO PORT, IT CANNOT BE TIGHTENED TO TIGHT IF NOT, IT CAN CAUSE THIS ISSUE OF THE PORT BREAKING. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE PORT WAS CRACKED BUT NOT DETACHED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12196419 ↗
• MalfunctionJun 21, 2021Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT THE IRIS FEEDING TUBE WAS PLACED ON (B)(6) 2021 AND BROKE ON (B)(6), 2021. A PHOTO WAS PROVIDED AND SHOWS THAT THE Y-PORT CRACKED AND A PORTION OF IT BROKE OFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12032207 ↗
• MalfunctionJun 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED A BROKEN (DETACHED) IRIS TUBE AT THE HUB. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11979217 ↗
• MalfunctionJun 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED A BROKEN IRIS TUBE AT THE HUB; THE CONNECTOR PIECE DETACHED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11936095 ↗
• MalfunctionMay 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE HUB BROKE AND DETACHED ON THE IRIS TUBE. THE TUBE WAS PLACED ON (B)(6) 2021 AND BROKE ON (B)(6) 2021. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11826990 ↗
• MalfunctionMay 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE KANGAROO IRIS TUBE BROKE AT THE HUB. THE TOP OF THE Y PORT THAT THE CAP PUSHES INTO, DETACHED FROM THE Y PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11825739 ↗
• MalfunctionApr 28, 2021Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT WHEN ATTEMPTING TO CHANGE THE TUBING, THE TUBE FEED SEEMED TO HAVE HARDENED AROUND THE PORT. WHEN ATTEMPTING TO UNSCREW THE TUBING, THE RUBBER PORTION OF THE DOBHOFF RIPPED, AND THE TOP PLASTIC PART CAME OFF WITH THE TUBING. THEY WERE UNABLE TO CONTINUE TUBE FEEDS AND THE PORT WAS LEAKY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11740144 ↗
• MalfunctionApr 28, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT ONE OF THE TWO LUER LOCK PORTS BROKE, CAUSING LEAKING AND ISSUES WITH THE NG TUBE. THE OTHER VALVE WAS NOT BROKEN BUT UNABLE TO GIVE FEEDINGS WITH THE OTHER PORT DE TO LOSS IN PRESSURE. WHEN ATTACHING THE TUBE FEEDING TO THE PORT YOU CANNOT TIGHTEN TOO TIGHT OR IT CAN CAUSE THIS ISSUE OF THE PORT BREAKING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11740047 ↗
• MalfunctionApr 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE KANGAROO IRIS TUBE BROKE AT THE HUB. THE TOP OF THE Y PORT THAT THE CAP PUSHES INTO, DETACHED FROM THE Y PORT. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11680408 ↗
• MalfunctionMar 29, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE HUB OF THE KANGAROO IRIS FEEDING TUBE WAS CRACKED AND LEAKING. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 11585932 ↗
• MalfunctionMar 25, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE DEVICE WAS CRACKED AND LEAKING. THE DEVICE WAS REMOVED. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 25-MAR-2021 STATED THAT THE PURPLE Y-PORT WAS CRACKED, NOT THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11571428 ↗
• InjuryFeb 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE CAMERA COMPONENT ON THE IRIS FEEDING TUBE BROKE OFF IN A PATIENT'S NARE. THE BEDSIDE RN WAS ABLE TO REMOVE THE LODGED CAMERA AT THE BEDSIDE. NO INJURY OR DISCOMFORT TO THE PATIENT WAS OBSERVED FOLLOWING THE EVENT. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER ON 29-JAN-2021 STATED THAT THE PATIENT IS AN ADULT MALE WITH HISTORY OF SELF-REMOVAL OF HIS NASOGASTRIC FEEDING TUBES; (B)(6) 2021 AND (B)(6) 2021. A NEW KANGAROO ENTERAL FEEDING TUBE WITH IRIS TECHNOLOGY, SIZE 10FR, WAS INSERTED INTO THE LEFT NARE AND SECURED WITH AN AMT BRIDLE NASAL RETAINING DEVICE SIZE 10FR BY NCCU NURSE AT 0950 ON (B)(6) 2021. PRIOR TO RE-INSERTING THE FEEDING TUBE, THE NURSE RECALLS NOTING A SMALL ABOUT OF DRIED BROWNISH NASAL MUCOUS AROUND THE RIGHT NARE, WHICH THE NURSE REMOVED. THE NURSE INSERTED THE FEEDING TUBE AND SECURED IT WITH AN AMT BRIDLE WITHOUT DIFFICULTY NOR DISTRESS TO THE PATIENT. THE NURSE ALSO RECALLS THAT SHE WAS ABLE TO VISUALLY IDENTIFY THE PATIENT'S INTERNAL ANATOMICAL LANDMARKS DURING INSERTION AND THAT PLACEMENT WAS VERIFIED WITH X-RAY PRIOR TO USE. ON THE SAME DAY OF INSERTION, THE DIRECT CARE NURSE OBSERVED THE FEEDING TUBE HAD BEEN SELF-REMOVED

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11269729 ↗
• MalfunctionJan 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT A PIECE OF THE Y-PORT CONNECTOR ON THE IRIS FEEDING TUBES BROKE OFF. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11127213 ↗
• MalfunctionDec 18, 2020No Display/Image; No Display/Image

  THE CUSTOMER REPORTED THAT WHEN ATTACHING THE IRIS FEEDING TUBE TO THE INTERFACE CABLE THE LIGHT DID NOT TURN ON AND THERE WAS NO IMAGE VISIBLE ON THE SCREEN. AFTER FURTHER ATTEMPTS AND OPENING MORE TUBES, THE LIGHT WENT ON AND VISUALIZATION ON THE CONSOLE WAS POSSIBLE. MID-PLACEMENT, THE SCREEN TURNED BLACK AND THE TUBE WOULD NOT RECONNECT. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2020 STATED THAT THE SCREEN WOULD TURN ON AND WORK THEN GO BLACK. THEY SWITCHED CABLES AND TUBES AND THE PROBLEM CONTINUED UNTIL THEY USED TUBES FROM A DIFFERENT LOT NUMBER. THEN IT WORKED FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11041527 ↗
• MalfunctionSep 8, 2020Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTS: THE FEEDING PORT COMPLETELY CAME OUT AND THE DEVICE THE FEED SPILLED OUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10504750 ↗
• MalfunctionJul 31, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE CUSTOMER REPORTED THE KANGAROO IRIS TUBE CRACKED AT THE SOFT RUBBER HUB WHERE MED PORT & FEEDING PORT CONNECT TOGETHER. THIS CAUSED A SMALL AMOUNT OF LEAKING FROM THE TUBE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10350474 ↗
• MalfunctionJul 29, 2020Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED THE FEEDING TUBE WAS CLOGGED IN THE DISTAL TIP JUST ABOVE THE EYELETS AFTER SEVERAL DAYS OF USE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10338645 ↗