Brand Name | FIRST PICC SL KIT |
Type of Device | CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM |
Manufacturer (Section D) |
ARGON MEDICAL DEVICES INC. |
1445 flat creek road |
athens TX 75751 |
|
Manufacturer (Section G) |
ARGON MEDICAL DEVICES INC. |
|
|
|
|
Manufacturer Contact |
gail
smith
|
1445 flat creek road |
athens, TX 75751
|
2144368995
|
|
MDR Report Key | 7405998 |
MDR Text Key | 104660143 |
Report Number | 1625425-2018-00030 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
Combination Product (y/n) | N |
PMA/PMN Number | K972262 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/08/2018 |
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? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 03/14/2020 |
Device Catalogue Number | 384232 |
Device Lot Number | 11171028 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
03/09/2018 |
Initial Date FDA Received | 04/08/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/14/2017 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|