Brand Name | EASYPUMP® II |
Type of Device | ELASTOMERIC INFUSION PUMP |
Manufacturer (Section D) |
B. BRAUN MELSUNGEN AG |
carl-braun-str. 1 |
melsungen, hessen 34212 |
GM 34212 |
|
Manufacturer (Section G) |
B. BRAUN MELSUNGEN AG |
carl-braun-str. 1 |
|
melsungen, 34212 |
GM
34212
|
|
Manufacturer Contact |
jonathan
severino
|
861 marcon blvd. |
allentown, PA 18109
|
4842408332
|
|
MDR Report Key | 8168863 |
MDR Text Key | 130479698 |
Report Number | 9610825-2018-00268 |
Device Sequence Number | 1 |
Product Code |
MEB
|
UDI-Device Identifier | 04046964448485 |
UDI-Public | (01)04046964448485(17)220301(10)17C04GE221 |
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K081905 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
12/17/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 03/01/2022 |
Device Model Number | N/A |
Device Catalogue Number | 4540008 |
Device Lot Number | 17C04GE221 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 12/17/2018 |
Distributor Facility Aware Date | 12/17/2018 |
Device Age | 21 MO |
Event Location |
Nursing Home
|
Date Report to Manufacturer | 12/17/2018 |
Initial Date Manufacturer Received |
11/19/2018
|
Initial Date FDA Received | 12/17/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/04/2017 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |