MalfunctionKNT
KANGAROO
Received Apr 17, 2026
Report 1423537-2026-00112 · MDR key 24916319
Device
Generic name
Tubes, Gastrointestinal (and Accessories)
Manufacturer
Cardinal Health 200, LlcModel number
461055ECatalog number
461055E
Lot number
1055081325
Product problems
- Break
Patient
48 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL PRODUCT CODE: PIF. ADDITIONAL 510K NUMBER: K123555. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION THE RESULTS WILL BE FORWARDED.
Description of Event or Problem
THE CUSTOMER REPORTED THE IRIS TUBE WAS BEING REMOVED AND THE NURSE NOTICED A BREAK IN THE TUBING. THERE WAS NO HARM TO THE PATIENT.