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