Brand Name | JELCO® VIAVALVE® SAFETY IV CATHETER |
Type of Device | CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
6000 nathan lane north |
minneapolis MN 55442 |
|
Manufacturer (Section G) |
SMITHS MEDICAL NORTH AMERICA |
201 west queen street |
|
southington CT 06489 |
|
Manufacturer Contact |
dave
halverson
|
6000 nathan lane north |
minneapolis, MN 55442
|
7633833310
|
|
MDR Report Key | 7389932 |
MDR Text Key | 104192453 |
Report Number | 3012307300-2018-00906 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
UDI-Device Identifier | 10351688077851 |
UDI-Public | 10351688077851 |
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | K113700 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign,health pr |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
08/02/2018 |
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 Expiration Date | 04/22/2019 |
Device Catalogue Number | 326800 |
Device Lot Number | 3417549 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/13/2018 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
03/08/2018 |
Initial Date FDA Received | 04/02/2018 |
Supplement Dates Manufacturer Received | 04/18/2018
|
Supplement Dates FDA Received | 08/02/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/02/2017 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|