Brand Name | 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 |
|
Manufacturer (Section G) |
NULL |
1500 eureka park |
|
ashford, kent TN25 4BF |
UK
TN25 4BF
|
|
Manufacturer Contact |
jim
vegel
|
6000 nathan lane north |
minneapolis, MN 55442
|
|
MDR Report Key | 13550246 |
MDR Text Key | 285755745 |
Report Number | 3012307300-2022-03561 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | 4033-AI |
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 |
04/27/2023 |
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 |
Health Professional
|
Device Catalogue Number | 4033-AI |
Device Lot Number | 4205143 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
01/19/2022 |
Initial Date FDA Received | 02/17/2022 |
Supplement Dates Manufacturer Received | 04/21/2023
|
Supplement Dates FDA Received | 04/26/2023
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/15/2021 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 3 MO |
Patient Sex | Male |
Patient Weight | 5 KG |
|
|