Brand Name | JELCO® I.V. 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 |
|
MDR Report Key | 7556961 |
MDR Text Key | 109746132 |
Report Number | 3012307300-2018-01994 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Type of Report
| Initial,Followup,Followup |
Report Date |
02/15/2019 |
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 | 07/19/2022 |
Device Catalogue Number | 4013-AI |
Device Lot Number | 3449020 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/05/2018 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
05/03/2018 |
Initial Date FDA Received | 05/31/2018 |
Supplement Dates Manufacturer Received | 06/04/2018 01/16/2019
|
Supplement Dates FDA Received | 07/03/2018 03/12/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|