Brand Name | EASYPUMP® II |
Type of Device | ELASTOMERIC INFUSION PUMP |
Manufacturer (Section D) |
B. BRAUN MELSUNGEN AG |
carl-braun-str. 1 |
melsunge |
|
Manufacturer (Section G) |
B. BRAUN MELSUNGEN AG |
carl-braun-str. 1 |
|
melsungen 34212 |
|
Manufacturer Contact |
jonathan
severino
|
861 marcon blvd. |
allentown, PA 18109
|
4847197287
|
|
MDR Report Key | 14960951 |
MDR Text Key | 304535041 |
Report Number | 9610825-2022-00270 |
Device Sequence Number | 1 |
Product Code |
MEB
|
UDI-Device Identifier | 04046964448485 |
UDI-Public | (01)04046964448485(17)261001(10)21L11GE221 |
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | K081905 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup,Followup |
Report Date |
11/09/2022 |
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 | 10/01/2022 |
Device Model Number | 4540008-02 |
Device Catalogue Number | 4540008 |
Device Lot Number | 21L11GE221 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/29/2022
|
Initial Date FDA Received | 07/08/2022 |
Supplement Dates Manufacturer Received | 06/29/2022 06/29/2022
|
Supplement Dates FDA Received | 11/09/2022 11/09/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |