Kangaroo 461503E (UDI 10884521547155)Recalls & reported problems
Cardinal Health, Inc. · Polyurethane Feeding Tube Radiopaque · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521547155), received between Aug 30, 2023 and Aug 30, 2023 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Necrosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THAT THEY HAVE SEEN AN INCREASE IN NEC (NECROTIZING ENTEROCOLITIS) IN THE NICU. THEY HAVE BEEN EXPLORING MULTIPLE AVENUES TO ASSESS WHAT COULD BE CONTRIBUTING TO THIS. AFTER WORKING WITH INFECTION PREVENTION AND OBTAINING CULTURES ON MULTIPLE PATIENTS, THEY HAVE DETERMINED THAT THE FINDINGS ARE CONCERNING WITH THE POSSIBILITY OF BACTERIA BEING INTRODUCED TO THEIR BABIES THROUGH THE ENTERAL FEEDING TUBES VIA THE MOAT. THEY HAVE TRIED MULTIPLE ROUTES TO CLEAN THE FEEDING TUBES - THE TWO DIFFERENT BRISTLE BRUSHES AND THE TOOTHBRUSH (SEE ATTACHMENT), DID NOT SEEM TO CLEAN THE 'MOAT' OF THE TUBES THOROUGHLY. THE SUGGESTION ON THE ATTACHED CLEANING PRACTICES WAS TO CLEAN THE MOAT ONCE A SHIFT. SO, THEY CAME UP WITH THEIR OWN PRACTICE TO FLUSH THE TUBES WITH 1CC STERILE WATER AND THEN RINSE THE MOAT WITH 2CC OF STERILE WATER AFTER EACH FEED AND TAP THE MOAT ONTO A STERILE GAUZE. THE CULTURES WERE OBTAINED AFTER THIS CLEANING PRACTICE WAS INITIATED AND THEY STILL HAVE THESE RESULTS AFTER CULTURE. PER ADDITIONAL INFORMATION RECEIVED, THE TUBES THAT WERE TESTED HAD BEEN USED. THEY DID NOT VISIBLY SEE SIGNS OF THE BACTERIA OR ANY FOREIGN SUBSTANCE IN THE MOAT OF THE TUBE
Patient problems: Necrosis
MAUDE report 17650217 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.