Brand Name | SAFEDRAW BLOOD SUPPLY SYSTEM |
Type of Device | BLOOD SUPPLY SYSTEM |
Manufacturer (Section D) |
MERIT MEDICAL SINGAPORE PTE LTD. |
198 yishun ave 7 |
singapore, 76892 6 |
SN 768926 |
|
MDR Report Key | 7954424 |
MDR Text Key | 123420028 |
Report Number | 8020616-2018-00049 |
Device Sequence Number | 1 |
Product Code |
DSK
|
Combination Product (y/n) | N |
PMA/PMN Number | K885235 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup |
Report Date |
09/11/2018 |
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 Catalogue Number | 689311 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/22/2018 |
Initial Date Manufacturer Received |
09/11/2018 |
Initial Date FDA Received | 10/10/2018 |
Supplement Dates Manufacturer Received | 11/22/2018
|
Supplement Dates FDA Received | 11/29/2018
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|