Brand Name | NIPRO SAFETOUCH II AVF NEEDLE |
Type of Device | AVF NEEDLE |
Manufacturer (Section D) |
NIPRO (THAILAND) CORP. LTD. |
10/2 moo 8 |
bangnomko, |
sena, ayuthaya 13110 , |
TH 13110, |
|
MDR Report Key | 16455786 |
MDR Text Key | 310380495 |
Report Number | 1056186-2023-00002 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
UDI-Device Identifier | 00383790000208 |
UDI-Public | 00383790000208 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
02/28/2023 |
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 Operator |
Health Professional
|
Device Model Number | FS+173230BC |
Device Catalogue Number | FS+173230BC |
Device Lot Number | 22H12J |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 02/28/2023 |
Distributor Facility Aware Date | 02/15/2023 |
Event Location |
Outpatient Diagnostic Facility
|
Date Report to Manufacturer | 02/28/2023 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 02/28/2023 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|