Brand Name | ARROW AGBA PICC/DELTA KIT: 1-L 4.5 FR X 50 CM |
Type of Device | INTRODUCER, CATHETER |
Manufacturer (Section D) |
ARROW INTERNATIONAL INC. |
reading PA |
|
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 | 13093384 |
MDR Text Key | 283092661 |
Report Number | 9680794-2021-00678 |
Device Sequence Number | 1 |
Product Code |
DYB
|
UDI-Device Identifier | 60801902120740 |
UDI-Public | 60801902120740 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
12/06/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/28/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Expiration Date | 03/31/2023 |
Device Model Number | IPN037304 |
Device Catalogue Number | CDC-45041-VPS2 |
Device Lot Number | 13F21J1117 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 01/25/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/18/2021 |
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 |
|
|