Brand Name | PRIMING SET FOR ARTERIAL BLOODLINES |
Manufacturer (Section D) |
REYNOSA MANUFACTURING |
reynosa |
MX |
|
Manufacturer (Section G) |
REYNOSA PLANT |
parque industrial reynosa |
|
reynosa, tamaulipas 8878 0 |
MX
88780
|
|
Manufacturer Contact |
tanya
taft, rn cnor
|
920 winter street |
waltham, MA 02451
|
8006621237
|
|
MDR Report Key | 3912042 |
MDR Text Key | 4584339 |
Report Number | 8030665-2014-00400 |
Device Sequence Number | 1 |
Product Code |
KOC
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K010268 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility,Company Representative |
Reporter Occupation |
No Information
|
Type of Report
| Initial |
Report Date |
04/15/2014 |
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 Expiration Date | 04/01/2016 |
Device Catalogue Number | 04-9006-5 |
Device Lot Number | 13DR01024 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
04/15/2014
|
Initial Date FDA Received | 05/13/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/01/2013 |
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 |
Treatment | HEMODIALYSIS MACHINE |
|
|