Brand Name | ANGIODYNAMICS / SMART PORT |
Type of Device | PORT & CATHETER, IMPLANTED |
Manufacturer (Section D) |
ANGIODYNAMICS |
10 glens falls technical park |
glens falls NY 12801 |
|
Manufacturer (Section G) |
ANGIODYNAMICS |
10 glens falls technical park |
|
glens falls NY 12801 |
|
Manufacturer Contact |
law
ryan
|
10 glens falls technical park |
glens falls, NY 12801
|
|
MDR Report Key | 8374855 |
MDR Text Key | 137292903 |
Report Number | 1317056-2019-00040 |
Device Sequence Number | 1 |
Product Code |
LJT
|
UDI-Device Identifier | H787CT80STPD0 |
UDI-Public | H787CT80STPD0 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K062414 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
02/27/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/27/2019 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 05/31/2021 |
Device Catalogue Number | H787CT80STPD0 |
Device Lot Number | 5344453 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 02/01/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/31/2018 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
Required Intervention;
|