MalfunctionKNT
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Received Jul 7, 2026 · Event occurred May 7, 2026
Report 1423537-2026-00221 · MDR key 25734230
Device
Generic name
Tubes, Gastrointestinal (and Accessories)
Manufacturer
Cardinal Health 200, LlcProduct problems
- Unintended Deflation
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED A GASTROSTOMY TUBE EQUIPMENT FAILURE. THE GASTROSTOMY TUBE IS NO LONGER STAYING IN PLACE AND IS SLIPPING OUT. UPON INSPECTION, THE BALLOON AND ITS FLUID APPEAR YELLOW RATHER THAN CLEAR, INDICATING A LEAK.
Additional Manufacturer Narrative
BOTH THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. AS A RESULT, THE UDI AND 510K NUMBERS COULD NOT BE DETERMINED. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION THE RESULTS WILL BE FORWARDED.