Brand Name | FIRST PICC S/L WITH STATLOCK STABILIZATION DEVICE |
Type of Device | FIRST PICC S/L |
Manufacturer (Section D) |
ARGON MEDICAL DEVICES |
1445 flat creek rd |
athens TX 75751 |
|
Manufacturer Contact |
kelly
mayer
|
1445 flat creek rd |
athens, TX 75751
|
9036759321
|
|
MDR Report Key | 19189225 |
MDR Text Key | 341470808 |
Report Number | 0001625425-2024-00997 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
UDI-Device Identifier | 00886333209774 |
UDI-Public | 00886333209774 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K972262 |
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 |
04/25/2024 |
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 |
Health Professional
|
Device Model Number | 384242 |
Device Lot Number | 11454701 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
03/27/2024
|
Initial Date FDA Received | 04/26/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/19/2022 |
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 |