FDA Adverse Event
Malfunction
Summary report: N
6300 ECON DRN BG W/ANTI REFLUX
MDR report key: 9194450
·
Received October 15, 2019
Report
- Report Number
- 9612030-2019-02323
- Event Type
- Malfunction
- Date Received
- October 15, 2019
- Date of Event
- October 9, 2019
- Report Date
- October 15, 2019
- Manufacturer
- COVIDIEN
- Product Code
- KNX
- UDI-DI
- 10884521002043
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 REPORTED THAT THE PORT AT THE TOP WAS WIDE/LOOSE RESULTING IN THE CATHETER NOT STAYING CONNECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 987968 | 6300 ECON DRN BG W/ANTI REFLUX | COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER | KNX | COVIDIEN | 6300 | 10884521002043 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |