Brand Name | PORT-A-CATH®II IMPLANTABLE ACCESS SYSTEMS |
Type of Device | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
6000 nathan lane north |
minneapolis MN 55442 |
|
Manufacturer (Section G) |
SMITHS MEDICAL ASD, INC. |
6000 nathan lane north |
|
minneapolis MN 55442 |
|
Manufacturer Contact |
dave
halverson
|
6000 nathan lane n |
minneapolis, MN 55442
|
7633833310
|
|
MDR Report Key | 7350647 |
MDR Text Key | 102803639 |
Report Number | 3012307300-2018-00637 |
Device Sequence Number | 1 |
Product Code |
LJT
|
UDI-Device Identifier | 10610586023552 |
UDI-Public | 10610586023552 |
Combination Product (y/n) | N |
Reporter Country Code | GR |
PMA/PMN Number | K962695 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/19/2018 |
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? |
No
|
Device Operator |
Physician
|
Device Expiration Date | 10/19/2021 |
Device Catalogue Number | 21-4055-24 |
Device Lot Number | 3349908 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
03/09/2018 |
Initial Date FDA Received | 03/19/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/01/2017 |
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) |
Hospitalization;
Required Intervention;
|