KANGAROO
Report
- Report Number
- 1423537-2025-00198
- Event Type
- Malfunction
- Date Received
- May 12, 2025
- Date of Event
- April 8, 2025
- Report Date
- September 24, 2025
- Manufacturer
- CARDINAL HEALTH 200, LLC
- Product Code
- KNT
- UDI-DI
- 10192253011562
- PMA / PMN Number
- K180622
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ADDITIONAL 510K NUMBER: K932295. ADDITIONAL PRODUCT CODE: PIF. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION THE RESULTS WILL BE FORWARDED.
THE DEVICE HISTORY RECORD (DHR) FOR LOT NUMBER 2400121964 WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE OBSERVED. THERE WERE NO SAMPLES RETURNED FOR EVALUATION; THEREFORE, THE AFFECTED DEVICE COULD NOT BE EVALUATED TO CONFIRM THE REPORTED ISSUE. AS SUCH, A ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. HOWEVER, A CORRECTIVE AND PREVENTATIVE ACTION HAS BEEN OPENED TO ADDRESS THE REPORTED ISSUE. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.
ONE DEVICE WAS RECEIVED FOR INVESTIGATION. THE DEVICE WAS INSPECTED, AND THE REPORTED CONDITION WAS OBSERVED. A SUPPLIER CORRECTIVE ACTION REQUEST HAS PREVIOUSLY BEEN SENT TO THE SUPPLIER TO FURTHER INVESTIGATE AND ADDRESS THE REPORTED CONDITION. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.
THE CUSTOMER REPORTED THAT DURING THE PROCEDURE IT WAS NOTED THAT THE PROBE CUFF WAS PUNCTURED. THERE WAS NO HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1825170 | KANGAROO | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | KNT | CARDINAL HEALTH 200, LLC | 8884720247 | 2400121964 | 10192253011562 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |