Brand Name | BROCKENBROUGH¿ NEEDLE |
Type of Device | TROCAR |
Manufacturer (Section D) |
MEDTRONIC MEXICO |
av. paseo del cucapah #10510 |
tijuana,bc 22570 |
MX 22570 |
|
Manufacturer (Section G) |
MEDTRONIC MEXICO |
av. paseo del cucapah #10510 |
|
tijuana,bc 22570 |
MX
22570
|
|
Manufacturer Contact |
paula
bixby
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635055378
|
|
MDR Report Key | 9858000 |
MDR Text Key | 192185146 |
Report Number | 9612164-2020-01245 |
Device Sequence Number | 1 |
Product Code |
DRC
|
UDI-Device Identifier | 00613994663146 |
UDI-Public | 00613994663146 |
Combination Product (y/n) | N |
PMA/PMN Number | PRE-AMEND |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/19/2020 |
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 | 02/19/2016 |
Device Model Number | EP003994S |
Device Catalogue Number | EP003994S |
Device Lot Number | 208050657 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
02/15/2015
|
Initial Date FDA Received | 03/19/2020 |
Date Device Manufactured | 02/19/2014 |
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 Age | 75 YR |
Patient Weight | 80 |
|
|