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Kangaroo 461438 (UDI 10884521067950)Recalls & reported problems

Cardinal Health 200, LLC · Radiopaque Line, Safe Enteral Connections · Class 2

Adverse event reports
9
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521067950), received between Mar 13, 2018 and Dec 4, 2020 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (2 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

  • Detachment Of Device Component2
  • Detachment of Device or Device Component2
  • Disconnection2
  • Material Separation2
  • Fracture1

Patient problems

  • No Consequences Or Impact To Patient5
  • No Known Impact Or Consequence To Patient3
  • No Information1

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 4, 2020Fracture; Fracture

    THE CUSTOMER REPORTED THAT THERE WAS A LARGE HOLE IN THE MIDDLE OF THE FEEDING TUBE. THERE WAS NO PATIENT HARM.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10945727 ↗
  • MalfunctionMar 2, 2020Disconnection; Disconnection

    THE CUSTOMER REPORTED THAT THE DEVICE WAS REPLACED DUE TO THE PURPLE END CAP BREAKING OFF. THERE WAS NO PATIENT INJURY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9776499 ↗
  • MalfunctionNov 21, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    THE CUSTOMER REPORTED THAT THE PURPLE TOP CAME APART FROM THE TUBE WITHOUT ANY FORCE ON THE PRODUCT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9354213 ↗
  • MalfunctionNov 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    THE CUSTOMER STATED THAT UPON ADMISSION, THE PATIENT WAS PLACED WITH A FEEDING TUBE. THE NEXT DAY, THE CAP ON THE FEEDING TUBE WAS DISCONNECTED AND WAS FOUND LYING NEXT TO THE BABY WITH THE TUBE STILL IN PLACE. NO PATIENT HARM REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9290345 ↗
  • MalfunctionSep 25, 2019Material Separation; Material Separation

    THE CUSTOMER REPORTED THAT THE PORT OF THE FEEDING TUBE BECAME DISCONNECTED FROM THE TUBE ITSELF. THERE WAS NO PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9119099 ↗
  • MalfunctionSep 24, 2019Material Separation; Material Separation

    THE CUSTOMER REPORTED THAT THE PORT OF THE FEEDING TUBE BECAME DISCONNECTED FROM THE TUBE ITSELF. THIS ISSUE WAS DISCOVERED WHILE THE PRODUCT WAS IN USE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9112939 ↗
  • MalfunctionJun 4, 2018Detachment Of Device Component; Detachment Of Device Component

    THE CUSTOMER REPORTED THAT A 6.5 FR POLYURETHANE FEEDING TUBE WAS SECURED IN PLACE. THE PURPLE CAP/TOP ACCESSED TO HOOK UP THE SYRINGE TO CHECK PLACEMENT AND PURPLE TOP DISCONNECTED. THERE WAS NO PATIENT INJURY REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7566623 ↗
  • MalfunctionMay 8, 2018Detachment Of Device Component; Detachment Of Device Component

    THE CUSTOMER REPORTED THE CONNECTION IS COMING APART FROM THE TUBE. THE PURPLE PORT ON THE FEED TUBE DETACHED FROM THE TUBE ITSELF.

    Patient problems: No Information

    MAUDE report 7494947 ↗
  • MalfunctionMar 13, 2018Disconnection

    WHILE ASSESSING THE PLACEMENT OF THE OG TUBE, THE ENTIRE PURPLE CAP DISCONNECTED FROM THE TUBING. I REMOVED THE OG TUBE FROM THE PATIENT AND REPLACED IT WITH A NEW TUBE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7337390 ↗

Other TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices

All TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.