FDA Adverse Event
Malfunction
Summary report: N
KANGAROO
MDR report key: 25209134
·
Received May 18, 2026
Report
- Report Number
- 1423537-2026-00161
- Event Type
- Malfunction
- Date Received
- May 18, 2026
- Date of Event
- April 9, 2026
- Report Date
- May 18, 2026
- Manufacturer
- CARDINAL HEALTH 200, LLC
- Product Code
- KNT
- UDI-DI
- 10192253007855
- PMA / PMN Number
- K163002
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL PRODUCT CODE: (B)(4). 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 A TEAR IN THE INSERTED PORTION OF THE NG TUBE WHICH WAS NOTED WHEN THE TUBE WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 469829 | KANGAROO | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | KNT | CARDINAL HEALTH 200, LLC | 461055E | 10192253007855 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Male |