| Brand Name | ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM |
|---|
| Type of Device | CATHETER PERCUTANEOUS |
|---|
| 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 |
|
elaine
cully
|
| 3015 carrington mill blvd |
| morrisville, NC 27560
|
|
|---|
| MDR Report Key | 19202430 |
|---|
| MDR Text Key | 341357531 |
|---|
| Report Number | 3006425876-2024-00395 |
|---|
| Device Sequence Number | 1 |
|---|
| Product Code |
DQY
|
| UDI-Device Identifier | 00801902100108 |
|---|
| UDI-Public | 00801902100108 |
|---|
| Combination Product (y/n) | N |
|---|
| Reporter Country Code | CH |
|---|
| PMA/PMN Number | K862056 |
|---|
| 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 |
|---|
| Report Date |
04/01/2024 |
|---|
| 1 Device was Involved in the Event |
|
| 1 Patient was Involved in the Event |
|
| Date FDA Received | 04/29/2024 |
|---|
| Is this an Adverse Event Report? |
No
|
|---|
| Is this a Product Problem Report? |
Yes
|
|---|
| Device Catalogue Number | CS-12122-F |
|---|
| Device Lot Number | 71F21J1163 |
|---|
| Was Device Available for Evaluation? |
No
|
|---|
| Date Manufacturer Received | 04/01/2024 |
|---|
| Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
|---|
| Date Device Manufactured | 09/15/2021 |
|---|
| 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 |
|---|
| Treatment | NONE REPORTED |
|---|
