Brand Name | JAMSHIDI BONE MARROW BIOPSY |
Type of Device | BONE BIOPSY NEEDLE |
Manufacturer (Section D) |
CAREFUSION, INC |
zona franca las americas |
santo domingo |
|
Manufacturer (Section G) |
CAREFUSION, INC |
zona franca las americas |
|
santo domingo |
|
Manufacturer Contact |
anna
wehrheim
|
75 n. fairview drive |
vernon hills, IL 60061
|
|
MDR Report Key | 7135416 |
MDR Text Key | 95729358 |
Report Number | 9680904-2017-00234 |
Device Sequence Number | 1 |
Product Code |
FSH
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K813338 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,other |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
02/08/2018 |
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 |
Other
|
Device Expiration Date | 01/31/2022 |
Device Catalogue Number | DJ4011X |
Device Lot Number | 1071107 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
11/27/2017 |
Initial Date FDA Received | 12/20/2017 |
Supplement Dates Manufacturer Received | 11/27/2017
|
Supplement Dates FDA Received | 02/08/2018
|
Was Device Evaluated by Manufacturer? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|