Brand Name | JELCO® 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 ITALIA S.R.L. |
via della stazione, 2 |
04010 latina scalo |
latina, |
IT
|
|
Manufacturer Contact |
dave
halverson
|
6000 nathan lane north |
minneapolis, MN 55442
|
7633833310
|
|
MDR Report Key | 7041185 |
MDR Text Key | 92331636 |
Report Number | 3012307300-2017-02445 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
01/02/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
No Information
|
Device Expiration Date | 06/07/2022 |
Device Catalogue Number | 4016-AI |
Device Lot Number | 3441090 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
10/24/2017 |
Initial Date FDA Received | 11/17/2017 |
Supplement Dates Manufacturer Received | 11/07/2017
|
Supplement Dates FDA Received | 01/02/2018
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/23/2017 |
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 |
Patient Outcome(s) |
Other;
|
Patient Age | 84 YR |
|
|