Brand Name | JELCO CONVENTIONAL JELCO IV CATHETER |
Type of Device | CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L |
Manufacturer (Section D) |
SMITHS MEDICAL INTERNATIONAL, LTD. |
1500 eureka park |
ashford, kent TN25 4BF |
UK TN25 4BF |
|
MDR Report Key | 10007285 |
MDR Text Key | 189305316 |
Report Number | 3012307300-2020-03452 |
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 |
foreign,user facility |
Type of Report
| Initial,Followup |
Report Date |
05/05/2020 |
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? |
Yes
|
Device Operator |
No Information
|
Device Expiration Date | 05/08/2024 |
Device Catalogue Number | 4033-AI |
Device Lot Number | 3816014 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
04/02/2020 |
Initial Date FDA Received | 04/28/2020 |
Supplement Dates Manufacturer Received | 05/01/2020
|
Supplement Dates FDA Received | 05/05/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Weight | 4 |
|
|