Brand Name | NIPRO BLOOD TUBING SET W/TRANSDUCER PROTECTOR |
Type of Device | BLOODLINE |
Manufacturer (Section D) |
NIPRO (THAILAND) CORP. LTD. |
10/2 moo 8 |
bangnomko, |
sena, ayuthaya 13110 , |
TH 13110, |
|
MDR Report Key | 11346753 |
MDR Text Key | 232504965 |
Report Number | 8041145-2021-00003 |
Device Sequence Number | 1 |
Product Code |
FJK
|
UDI-Device Identifier | 00383790004053 |
UDI-Public | 00383790004053 |
Combination Product (y/n) | N |
PMA/PMN Number | K072024 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Type of Report
| Initial,Followup |
Report Date |
03/24/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/18/2021 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | BL+A209Y/V803 |
Device Catalogue Number | BL+A209Y/V803 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/18/2021 |
Date Manufacturer Received | 01/19/2021 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Death;
|
|
|