Brand Name | BD INTIMA II¿ IV CATHETER |
Type of Device | INTRAVASCULAR CATHETER |
Manufacturer (Section D) |
BD (SUZHOU) |
no. 5 baiyu road |
suzhou industrial park |
suzhou |
|
Manufacturer (Section G) |
BD (SUZHOU) |
no. 5 baiyu road |
suzhou industrial park |
suzhou |
|
Manufacturer Contact |
brett
wilko
|
9450 south state street |
sandy, UT 84070
|
8015652845
|
|
MDR Report Key | 7848554 |
MDR Text Key | 119496210 |
Report Number | 3006948883-2018-00170 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K143610 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,o |
Reporter Occupation |
|
Type of Report
| Initial,Followup |
Report Date |
09/24/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/05/2018 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Expiration Date | 04/19/2021 |
Device Catalogue Number | 383403 |
Device Lot Number | 8079185 |
Was Device Available for Evaluation? |
No Answer Provided
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 08/16/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/20/2018 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Treatment Data |
Date Received: 09/05/2018 Patient Sequence Number: 1 |
|
|