Brand Name | BROVIAC CV CATHETER, SINGLE-LUMEN, 4.2F |
Type of Device | CHRONIC CATHETERS |
Manufacturer (Section D) |
C.R. BARD, INC. (BASD) -3006260740 |
605 north 5600 west |
salt lake city 84116 |
|
Manufacturer (Section G) |
BARD SHANNON LIMITED -3005636544 |
san geronimo industrial park |
lot #1, road #3, km 79.7 |
humacao PR 00791 |
|
Manufacturer Contact |
brett
curtice
|
800 w. rio salado pkwy |
tempe, AZ 85281
|
4803032689
|
|
MDR Report Key | 18666140 |
MDR Text Key | 334844443 |
Report Number | 3006260740-2024-00394 |
Device Sequence Number | 1 |
Product Code |
LJS
|
UDI-Device Identifier | 00801741051807 |
UDI-Public | (01)00801741051807 |
Combination Product (y/n) | N |
Reporter Country Code | NZ |
PMA/PMN Number | K830256 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Health Professional,User Facility,Company Representative,Distributor |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
03/08/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/08/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 0600520 |
Device Lot Number | HUGX1438 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Manufacturer Received | 03/07/2024 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/23/2022 |
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 |
|
|