Brand Name | ARROW AGBA VPS PICC KIT: 1-L 4.5 FR X 55 CM |
Type of Device | CATHETER,INTRAVASCULAR,THERAPE |
Manufacturer (Section D) |
ARROW INTERNATIONAL LLC |
morrisville NC |
|
Manufacturer (Section G) |
ARROW INTERNATIONAL DE MEXICO S.A. DE C.V. |
ave. washington 3701 |
colonia panamericana, chihuahua |
chihuahua 31200 |
MX
31200
|
|
Manufacturer Contact |
katharine
tarpley
|
3015 carrington mill blvd |
morrisville, NC 27560
|
|
MDR Report Key | 14634209 |
MDR Text Key | 295493923 |
Report Number | 9680794-2022-00366 |
Device Sequence Number | 1 |
Product Code |
LJS
|
UDI-Device Identifier | 10801902192551 |
UDI-Public | 10801902192551 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K153487 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
05/23/2022 |
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 Expiration Date | 07/31/2023 |
Device Model Number | IPN920208 |
Device Catalogue Number | ASK-45541-CRMC |
Device Lot Number | 13F22C0334 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
05/23/2022 |
Initial Date FDA Received | 06/08/2022 |
Supplement Dates Manufacturer Received | 07/06/2022
|
Supplement Dates FDA Received | 07/06/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/07/2022 |
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 |
Patient Sex | Female |
|
|