Brand Name | FAST-CATH¿ TRIO HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 14 |
Type of Device | INTRODUCER, CATHETER |
Manufacturer (Section D) |
ST. JUDE MEDICAL |
5050 nathan lane north |
plymouth MN 55442 |
|
Manufacturer (Section G) |
ST. JUDE MEDICAL (AFD-PLYMOUTH) |
5050 nathan lane north |
|
plymouth MN 55442 |
|
Manufacturer Contact |
stephanie
o' sullivan
|
5050 nathan lane north |
plymouth, MN 55442
|
6517565400
|
|
MDR Report Key | 9507805 |
MDR Text Key | 190806088 |
Report Number | 3005334138-2019-00969 |
Device Sequence Number | 1 |
Product Code |
DYB
|
UDI-Device Identifier | 05414734203906 |
UDI-Public | 05414734203906 |
Combination Product (y/n) | N |
Reporter Country Code | MY |
PMA/PMN Number | K061015 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Remedial Action |
Recall |
Type of Report
| Initial,Followup |
Report Date |
01/20/2020 |
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 | 07/31/2022 |
Device Model Number | 406303 |
Device Catalogue Number | 406303 |
Device Lot Number | 7133555 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
11/22/2019 |
Initial Date FDA Received | 12/20/2019 |
Supplement Dates Manufacturer Received | 01/03/2020
|
Supplement Dates FDA Received | 01/20/2020
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/14/2019 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | SEE H10 |
Patient Sequence Number | 1 |
|
|