Brand Name | VACUETTE TUBE 6 ML K2E K2EDTA 13X100 PINK CAP-PINK RING, NON-RIDGED |
Type of Device | EVACUATED BLOOD COLLECTION TUBE |
Manufacturer (Section D) |
GREINER BIO-ONE NA INC. |
4238 capital drive |
monroe NC 28110 |
|
Manufacturer (Section G) |
GREINER BIO-ONE NA INC. |
4238 capital drive |
|
monroe NC 28110 |
|
Manufacturer Contact |
manfred
abel
|
4238 capital drive |
monroe, NC 28110
|
7042617823
|
|
MDR Report Key | 12605288 |
MDR Text Key | 277376504 |
Report Number | 1125230-2021-00078 |
Device Sequence Number | 1 |
Product Code |
JKA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K971236 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other Health Care Professional
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
10/11/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/11/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 11/10/2022 |
Device Model Number | 456279 |
Device Catalogue Number | 456279 |
Device Lot Number | B21053R8 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 09/21/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/11/2021 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Removal/Correction Number | RES# 88511 |
Patient Sequence Number | 1 |