Brand Name | HEMODIALYSIS BLOODLINES |
Type of Device | SET, TUBING, BLOOD, WITH A |
Manufacturer (Section D) |
B. BRAUN DOMINICIAN REPULIC INC. |
las americas industrial park |
km22 autopista las americas |
santo domingo, |
DR |
|
Manufacturer (Section G) |
B. BRAUN DOMINICIAN REPULIC INC. |
las americas industrial park |
km22 autopista las americas |
santo domingo, |
DR
|
|
Manufacturer Contact |
jonathan
severino
|
901 marcon blvd. |
allentown, PA 18109
|
4847197287
|
|
MDR Report Key | 18660113 |
MDR Text Key | 334772824 |
Report Number | 2523676-2024-00105 |
Device Sequence Number | 1 |
Product Code |
FJK
|
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 |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
02/07/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/07/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | SL-2000M2095DA |
Device Lot Number | 0061888517 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 01/25/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 05/19/2023 |
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 |
|
|