Brand Name | BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN |
Type of Device | BLOOD SPECIMEN COLLECTION DEVICE |
Manufacturer (Section D) |
BECTON, DICKINSON & CO. (BROKEN BOW) |
150 south 1st avenue |
broken bow NE 68822 |
|
Manufacturer (Section G) |
BECTON, DICKINSON & CO. (BROKEN BOW) |
150 south 1st avenue |
|
broken bow NE 68822 |
|
Manufacturer Contact |
phillip
emmert
|
9450 south state street |
sandy, UT 84070
|
8015296192
|
|
MDR Report Key | 16056381 |
MDR Text Key | 306711845 |
Report Number | 1917413-2022-00812 |
Device Sequence Number | 1 |
Product Code |
JKA
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K891407 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
12/12/2022 |
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 |
Other
|
Device Model Number | 362753 |
Device Catalogue Number | 362753 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/30/2022 |
Initial Date FDA Received | 12/27/2022 |
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 |