Brand Name | BD NEXIVA 20 GA X 1-1/4 IN SINGLE PORT |
Type of Device | INTRAVASCULAR CATHETER |
Manufacturer (Section D) |
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. |
9450 south state street |
sandy UT 84070 |
|
Manufacturer (Section G) |
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. |
9450 south state street |
|
sandy UT 84070 |
|
Manufacturer Contact |
helen
cox (mdr)
|
75 north fairway drive |
vernon hills, IL 60061
|
8473935694
|
|
MDR Report Key | 18696976 |
MDR Text Key | 336290558 |
Report Number | 1710034-2024-00099 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K183399 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility |
Reporter Occupation |
Other Health Care Professional
|
Report Date |
02/01/2024 |
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 |
Other
|
Device Catalogue Number | 383517 |
Device Lot Number | 3059788 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 02/13/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/28/2023 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |