Brand Name | NIPRO BLOOD TUBING SET W/TRANSDUCER PROTECTOR |
Type of Device | BLOODLINES |
Manufacturer (Section D) |
NIPRO (THAILAND) CORP., LTD. |
10/2 moo 8, |
bangnomko, sena |
ayuthaya, thailand, 13110 |
TH 13110 |
|
Manufacturer (Section G) |
NIPRO (THAILAND) CORP., LTD. |
10/2 moo 8, |
bangnomko, sena |
ayuthaya, thailand, 13110 |
TH
13110
|
|
Manufacturer Contact |
michelle
tejada
|
3150 nw 107th avenue |
miami, FL 33172
|
3055997174
|
|
MDR Report Key | 6296549 |
MDR Text Key | 66460894 |
Report Number | 8041145-2017-00002 |
Device Sequence Number | 1 |
Product Code |
FJK
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K072024 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,user facility |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup,Followup |
Report Date |
02/02/2017,06/01/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/02/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | BL+A209Y/V803 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/13/2017 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 02/02/2017 |
Distributor Facility Aware Date | 01/06/2017 |
Event Location |
Outpatient Treatment Facility
|
Date Report to Manufacturer | 02/02/2017 |
Date Manufacturer Received | 01/11/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
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 |
Patient Outcome(s) |
Other;
|
|
|