Brand Name | SINGLE NEEDLE BLOOD TUBING SET |
Manufacturer (Section D) |
ERIKA DE REYNOSA, S.A. DE C.V. |
brecha e99 sur; parque |
industrial reynos, bldg. ii |
cd, reynosa, tamps |
MX |
|
Manufacturer (Section G) |
ERIKA DE REYNOSA, S.A. DE C.V. |
brecha e99 sur; parque |
industrial reynos, bldg. ii |
cd, reynosa, tamps |
MX
|
|
Manufacturer Contact |
jennifer
nabukenya
|
brecha e99 sur; parque |
industrial reynos, bldg. ii |
cd, reynosa, tamps
|
MX
|
8006621237
|
|
MDR Report Key | 3721012 |
MDR Text Key | 4233910 |
Report Number | 8030665-2014-00222 |
Device Sequence Number | 1 |
Product Code |
FJK
|
Combination Product (y/n) | N |
PMA/PMN Number | K0000451 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer,Company Representative |
Reporter Occupation |
Patient
|
Type of Report
| Initial |
Report Date |
02/10/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/12/2014 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 06/01/2016 |
Device Catalogue Number | 03-2696-7 |
Device Lot Number | 13HR01015 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 02/10/2014 |
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 |
Initial
|
Patient Sequence Number | 1 |
Treatment | FRESENIUS 2008K@ HOME MACHINE |
|
|