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 - CLEVELAND |
911 highway 61 north |
po box 1058 |
cleveland MS 38732 |
|
Manufacturer Contact |
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242702068
|
|
MDR Report Key | 16526147 |
MDR Text Key | 311164293 |
Report Number | 1416980-2023-00995 |
Device Sequence Number | 1 |
Product Code |
KDJ
|
UDI-Device Identifier | 00085412007694 |
UDI-Public | (01)00085412007694 |
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K152129 |
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 |
04/07/2023 |
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 | 5C4466P |
Device Lot Number | GD912372 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/03/2023 |
Initial Date Manufacturer Received |
02/14/2023
|
Initial Date FDA Received | 03/10/2023 |
Supplement Dates Manufacturer Received | 03/14/2023
|
Supplement Dates FDA Received | 04/07/2023
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/15/2022 |
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 |
Patient Sex | Male |
|
|