FDA Adverse Event
Malfunction
Summary report: N
ENTRFLX 12FR;43IN W/STYL YPOR
MDR report key: 8688170
·
Received June 11, 2019
Report
- Report Number
- 9612030-2019-02199
- Event Type
- Malfunction
- Date Received
- June 11, 2019
- Report Date
- June 11, 2019
- Manufacturer
- COVIDIEN
- Product Code
- KNT
- UDI-DI
- 10884521583030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF ADDITIONAL INFORMATION OR THE SAMPLE IS RECEIVED, THE INVESTIGATION WILL BE REOPENED AND RESPONDED TO ACCORDINGLY.
Description of Event or Problem · 1
THE CUSTOMER REPORTS THAT ON (B)(6) 2019 THE NJT WAS PLACED DURING ENDOSCOPY. ENTERAL FEEDS COMMENCED. THE PATIENT WAS EDUCATED REGARDING HOME FEEDS AND FLUSHING. ONCE HOME, THE PATIENT STATED THAT THE FEEDING TUBE BECAME BLOCKED. ALSO, WHEN THE PATIENT CHANGED THE NASO FIX DRESSING SHE NOTED THAT THERE WAS A HOLE IN TUBE JUST NEAR INSERTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 480157 | ENTRFLX 12FR;43IN W/STYL YPOR | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | KNT | COVIDIEN | 8884721252E | UNKNOWN | 10884521583030 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |