Brand Name | ARROW PICC SET: 2-LUMEN 16 GA X 50 CM |
Type of Device | CATHETER, INTRAVASCULAR, THERAPEUTIC |
Manufacturer (Section D) |
ARROW INTERNATIONAL LLC |
morrisville NC |
|
Manufacturer (Section G) |
ARROW INTERNATIONAL CR, A.S. |
jamska 2359/47 |
|
zdar nad sazavou 591 0 1 |
EZ
591 01
|
|
Manufacturer Contact |
kevin
don bosco
|
3015 carrington mill blvd |
morrisville, NC 27560
|
|
MDR Report Key | 19164671 |
MDR Text Key | 340837763 |
Report Number | 3006425876-2024-00365 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
Combination Product (y/n) | N |
Reporter Country Code | SP |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,User Facility,Distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
03/26/2024 |
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 | IPN919468 |
Device Catalogue Number | IB-01652 |
Device Lot Number | 71F23H0255 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
03/26/2024
|
Initial Date FDA Received | 04/23/2024 |
Supplement Dates Manufacturer Received | 05/23/2024
|
Supplement Dates FDA Received | 05/24/2024
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/07/2023 |
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 |
Treatment | NONE REPORTED; NONE REPORTED |