Brand Name | VPS 18GA 1.3MM OD 32MM L INSTAFLASH |
Type of Device | INTRAVASCULAR CATHETER |
Manufacturer (Section D) |
BECTON DICKINSON MEDICAL (SINGAPORE) |
30 tuas avenue 2 |
singapore |
|
Manufacturer (Section G) |
BECTON DICKINSON MEDICAL (SINGAPORE) |
30 tuas avenue 2 |
|
singapore |
|
Manufacturer Contact |
katie
swenson
|
9450 south state street |
sandy, UT 84070
|
8015296192
|
|
MDR Report Key | 12437151 |
MDR Text Key | 271496686 |
Report Number | 8041187-2021-00804 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
Combination Product (y/n) | N |
Reporter Country Code | SW |
PMA/PMN Number | NA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,other,user facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
08/25/2021 |
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 |
Other
|
Device Expiration Date | 12/31/2023 |
Device Catalogue Number | 393282 |
Device Lot Number | 1007458 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/09/2021 |
Initial Date FDA Received | 09/07/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/16/2021 |
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) |
Required Intervention;
|