| Brand Name | ARROW PICC KIT: 3 FR X 55 CM |
|---|
| Common Device Name | CATHETER,INTRAVASCULAR,THERAP |
|---|
| 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 |
|
angela
meister
|
| 3015 carrington mill blvd |
| morrisville 27560
|
|
|---|
| MDR Report Key | 50843189 |
|---|
| Report Number | 9680794-2026-00695 |
|---|
| Device Sequence Number | 10461446 |
|---|
| Product Code |
PWR
|
| UDI-Device Identifier | 60801902123420 |
|---|
| Combination Product (Y/N) | N |
|---|
| Initial Reporter State | MD |
|---|
| Initial Reporter Country | US |
|---|
| Number of Events Summarized | 1 |
|---|
| Summary Report (Y/N) | N |
|---|
| Reporter Type |
Manufacturer
|
|---|
| Report Source |
User Facility,Company Representative |
|---|
| Type of Report
| Initial |
|---|
| Report Date (Section B) |
08/25/2026 |
|---|
| 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 Catalogue Number | CDC-05531-PK1A |
|---|
| Device Lot Number | 33F26E0155 |
|---|
| Was Device Available for Evaluation? |
Yes
|
|---|
| Date Returned to Manufacturer | 09/09/2026 |
|---|
| Is the Reporter a Health Professional? |
No
|
|---|
| Type of Report(Section G) | Thirty-Day |
|---|
| Initial Date Received by Manufacturer | 08/25/2026 |
|---|
| Initial Report FDA Received Date | 09/21/2026 |
|---|
| Was Device Evaluated by Manufacturer? (Y/N) |
No
|
|---|
| Date Device Manufactured | 06/05/2026 |
|---|
| Is the Device Labeled for Single Use? (Y/N) |
Yes
|
|---|
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N) |
No
|
|---|
| Usage of Device |
Initial
|
|---|
| Patient Sequence Number | 1 |
|---|
| Patient Sex | Unknown |
|---|
