Brand Name | BD NEXIVA SINGLE PORT |
Type of Device | PERIPHERAL IV 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 | 19202262 |
MDR Text Key | 341819575 |
Report Number | 1710034-2024-00368 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
UDI-Device Identifier | 00382903835560 |
UDI-Public | (01)00382903835560 |
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,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
04/05/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/29/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 383556 |
Device Lot Number | 3310341 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 04/03/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |