Brand Name | POWERPORT CV SLIM SPNB 6 FR CHRONOFLEX SLTH |
Type of Device | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR |
Manufacturer (Section D) |
BARD ACCESS SYSTEMS |
605 n. 5600 w. |
salt lake city UT 84116 |
|
Manufacturer (Section G) |
BARD REYNOSA S.A. DE C.V. |
blvd montebello #1 |
parque industrial colonial |
reynosa tamaulipas 88780 |
MX
88780
|
|
Manufacturer Contact |
judith
ludwig
|
1415 w. 3rd street |
tempe, AZ 85281
|
4803032689
|
|
MDR Report Key | 9211268 |
MDR Text Key | 164291330 |
Report Number | 3006260740-2019-03203 |
Device Sequence Number | 1 |
Product Code |
LJT
|
UDI-Device Identifier | 00801741110771 |
UDI-Public | (01)00801741110771 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
10/18/2019 |
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 |
No Information
|
Device Model Number | 5676300 |
Device Catalogue Number | 5676300 |
Device Lot Number | RECX3530 |
Initial Date Manufacturer Received |
09/30/2019 |
Initial Date FDA Received | 10/18/2019 |
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|