FDA Adverse Event
Malfunction
Summary report: N
COVIDIEN
MDR report key: 25028381
·
Received April 29, 2026
Report
- Report Number
- 1423537-2026-00123
- Event Type
- Malfunction
- Date Received
- April 29, 2026
- Date of Event
- January 16, 2026
- Report Date
- April 29, 2026
- Manufacturer
- CARDINAL HEALTH, INC
- Product Code
- KNT
- UDI-DI
- 10884521661721
- PMA / PMN Number
- K180622
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL PRODUCT CODE: PIF. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 0
THE CUSTOMER REPORTED THE EXCHANGE WAS CARRIED OUT AND AFTER 5 DAYS THE BALLOON RUPTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 493871 | COVIDIEN | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | KNT | CARDINAL HEALTH, INC | 8884720221E | 2234015464 | 10884521661721 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |