Brand Name | ARROW SPINAL ANESTHESIA KIT: 25 GA X 9 CM |
Type of Device | NEEDLE, CONDUCTION, ANESTHETI |
Manufacturer (Section D) |
ARROW INTERNATIONAL LLC |
morrisville NC |
|
Manufacturer (Section G) |
ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V |
ave. washington 3701, edificio 4 |
colonia complejo industrial, las americas |
chihuahua 31114 |
MX
31114
|
|
Manufacturer Contact |
mariah
mackinnon
|
3015 carrington mill blvd |
morrisville, NC 27560
|
|
MDR Report Key | 18254253 |
MDR Text Key | 329551959 |
Report Number | 9680794-2023-00927 |
Device Sequence Number | 1 |
Product Code |
BSP
|
UDI-Device Identifier | 10801902064070 |
UDI-Public | 10801902064070 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K911260 |
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 |
11/08/2023 |
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 | ASK-24090-SPH |
Device Lot Number | 33F23F0069 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/13/2023 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
11/08/2023 |
Initial Date FDA Received | 12/04/2023 |
Supplement Dates Manufacturer Received | 12/19/2023
|
Supplement Dates FDA Received | 12/20/2023
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/07/2023 |
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 | NOT REPORTED; NOT REPORTED |
Patient Sex | Female |