Brand Name | JELCO CONVENTIONAL PLUS IV CATHETERS |
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 INTERNATIONAL LTD |
1500, eureka park |
lower pemberton |
ashford, kent TN25 4BF |
UK
TN25 4BF
|
|
Manufacturer Contact |
dave
halverson
|
1265 grey fox road |
st. paul, MN 55112
|
7633833310
|
|
MDR Report Key | 7611405 |
MDR Text Key | 111442009 |
Report Number | 3012307300-2018-02476 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
Combination Product (y/n) | N |
Reporter Country Code | BR |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Pharmacist
|
Type of Report
| Initial |
Report Date |
06/18/2018 |
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 |
No Information
|
Device Expiration Date | 02/07/2022 |
Device Catalogue Number | 7066-AB7 |
Device Lot Number | 3344361 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
05/28/2018 |
Initial Date FDA Received | 06/18/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/17/2017 |
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 |
|
|