Brand Name | HEMODIALYSIS BLOODLINES |
Type of Device | SET, TUBING, BLOOD, WITH A |
Manufacturer (Section D) |
B. BRAUN MEDICAL INC. |
824 12th avenue |
bethlehem PA 18018 0027 |
|
Manufacturer (Section G) |
B. BRAUN MEDICAL INC. |
824 12th avenue |
|
bethlehem PA 18018 0027 |
|
Manufacturer Contact |
jonathan
severino
|
901 marcon blvd. |
allentown, PA 18109
|
4847197287
|
|
MDR Report Key | 15217443 |
MDR Text Key | 305505208 |
Report Number | 2521402-2022-00050 |
Device Sequence Number | 1 |
Product Code |
FJK
|
UDI-Device Identifier | 04046964367786 |
UDI-Public | (01)04046964367786 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K080807 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Health Professional,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
10/18/2022 |
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 Model Number | SL-2010M2096 |
Device Catalogue Number | SL-2010M2096 |
Device Lot Number | 11054018 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/26/2022
|
Initial Date FDA Received | 08/12/2022 |
Supplement Dates Manufacturer Received | 07/26/2022
|
Supplement Dates FDA Received | 10/18/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/19/2021 |
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 |
|
|