Brand Name | NON-VENTED BLOOD SET |
Type of Device | BLOOD SET |
Manufacturer (Section D) |
CAREFUSION |
10020 pacific mesa blvd |
san diego CA 92121 4386 |
|
MDR Report Key | 7561388 |
MDR Text Key | 110036216 |
Report Number | 9616066-2018-00669 |
Device Sequence Number | 1 |
Product Code |
BRZ
|
Combination Product (y/n) | N |
PMA/PMN Number | K050115 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Type of Report
| Initial,Followup |
Report Date |
05/11/2018 |
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 |
Health Professional
|
Device Model Number | 10010903 |
Device Catalogue Number | 10010903 |
Other Device ID Number | 7613203020879 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
05/11/2018 |
Initial Date FDA Received | 06/01/2018 |
Supplement Dates Manufacturer Received | 05/11/2018
|
Supplement Dates FDA Received | 06/12/2018
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | 8015, 8100, THERAPY DATE UNK |
|
|