FDA Adverse Event
Malfunction
Summary report: N
3450 VYL CATH TRAY A PVI
MDR report key: 9746170
·
Received February 24, 2020
Report
- Report Number
- 9612030-2020-02417
- Event Type
- Malfunction
- Date Received
- February 24, 2020
- Date of Event
- February 19, 2020
- Report Date
- February 24, 2020
- Manufacturer
- COVIDIEN
- Product Code
- FCM
- UDI-DI
- 10884521009479
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- 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 CONNECTION BETWEEN THE CATHETER AND THE BAG COMES APART EASILY WHEN INSERTING THE LINE INTO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 207438 | 3450 VYL CATH TRAY A PVI | TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT) | FCM | COVIDIEN | 3450 | 10884521009479 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |