Brand Name | JAMSHIDI NEEDLE BONE MARROW 11GX4 ASP |
Type of Device | TRAY, SURGICAL, NEEDLE |
Manufacturer (Section D) |
CAREFUSION, INC |
75 north fairway drive |
vernon hills IL 60061 |
|
Manufacturer (Section G) |
CAREFUSION, INC |
zona franca las americas |
|
santo domingo |
DR
|
|
Manufacturer Contact |
anna
wehrheim
|
75 north fairway drive |
vernon hills, IL 60061
|
|
MDR Report Key | 6644301 |
MDR Text Key | 77656727 |
Report Number | 9680904-2017-00110 |
Device Sequence Number | 1 |
Product Code |
FSH
|
Combination Product (y/n) | N |
PMA/PMN Number | K813338 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
07/31/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | DJ4011X |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/20/2017 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
06/02/2017 |
Initial Date FDA Received | 06/15/2017 |
Supplement Dates Manufacturer Received | 06/02/2017
|
Supplement Dates FDA Received | 07/31/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|