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 |
|
Manufacturer (Section G) |
MERIT MEDICAL SINGAPORE PTE LTD. |
198 yishun ave 7 |
|
singapore, 76892 6 |
SN
768926
|
|
Manufacturer Contact |
katie
swenson cqe,cba,cqpa.
|
1600 merit parkway |
south jordan, UT 84095
|
8012531600
|
|
MDR Report Key | 8056278 |
MDR Text Key | 126704137 |
Report Number | 8020616-2018-00061 |
Device Sequence Number | 1 |
Product Code |
DSK
|
Combination Product (y/n) | N |
Reporter Country Code | NL |
PMA/PMN Number | K885235 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
10/18/2018 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 688420 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
10/18/2018
|
Initial Date FDA Received | 11/09/2018 |
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 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
Disability;
|