FDA Adverse Event
Malfunction
Summary report: N
KANGAROO
MDR report key: 24916319
·
Received April 17, 2026
Report
- Report Number
- 1423537-2026-00112
- Event Type
- Malfunction
- Date Received
- April 17, 2026
- Report Date
- May 6, 2026
- Manufacturer
- CARDINAL HEALTH 200, LLC
- Product Code
- KNT
- UDI-DI
- 10192253007855
- PMA / PMN Number
- K163002
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
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 · 0
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 69242 | KANGAROO | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | KNT | CARDINAL HEALTH 200, LLC | 461055E | 1055081325 | 10192253007855 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |