Brand Name | MINICAP TRANSFER SET |
Type of Device | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE |
Manufacturer (Section D) |
BAXTER HEALTHCARE - MOUNTAIN HOME |
mountain home AR |
|
Manufacturer (Section G) |
BAXTER HEALTHCARE - MOUNTAIN HOME |
1900 n highway 201 |
|
mountain home AR 72653 |
|
Manufacturer Contact |
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242702068
|
|
MDR Report Key | 7736499 |
MDR Text Key | 115609408 |
Report Number | 1416980-2018-04782 |
Device Sequence Number | 1 |
Product Code |
KDJ
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | NA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Nurse
|
Type of Report
| Initial,Followup |
Report Date |
08/28/2018 |
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 Catalogue Number | R5C4482 |
Device Lot Number | H17I18053 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/04/2018 |
Initial Date FDA Received | 07/31/2018 |
Supplement Dates Manufacturer Received | 08/08/2018
|
Supplement Dates FDA Received | 08/28/2018
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|