Brand Name | RATE FLOW® |
Type of Device | CONTROLLER, INFUSION, INTRAVASCULAR, ELECTRONIC |
Manufacturer (Section D) |
LEVENTON, S.A.U. |
newton, 18-24 |
sant esteve sesrovires, barcelona 08635 |
SP 08635 |
|
MDR Report Key | 7914872 |
MDR Text Key | 122003296 |
Report Number | 2532083-2018-00011 |
Device Sequence Number | 1 |
Product Code |
LDR
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
09/27/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/27/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 05/10/2021 |
Device Catalogue Number | US5300 |
Device Lot Number | 180946L |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/25/2018 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 09/27/2018 |
Distributor Facility Aware Date | 09/07/2018 |
Event Location |
Home
|
Date Report to Manufacturer | 09/14/2018 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|