Brand Name | MINICAP |
Type of Device | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE |
Manufacturer (Section D) |
BAXTER HEALTHCARE CORPORATION |
deerfield IL |
|
Manufacturer (Section G) |
BAXTER HEALTHCARE - SWINFORD |
foxford road |
|
swinford |
EI
|
|
Manufacturer Contact |
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242702068
|
|
MDR Report Key | 18685878 |
MDR Text Key | 335143559 |
Report Number | 1416980-2024-00475 |
Device Sequence Number | 1 |
Product Code |
KDJ
|
Combination Product (y/n) | N |
Reporter Country Code | KS |
PMA/PMN Number | NA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Consumer,Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
02/28/2024 |
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 |
Lay User/Patient
|
Device Catalogue Number | ABPC4466 |
Device Lot Number | ASKU |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
01/16/2024
|
Initial Date FDA Received | 02/12/2024 |
Supplement Dates Manufacturer Received | 02/26/2024
|
Supplement Dates FDA Received | 02/28/2024
|
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 |
|
|