Brand Name | POWERPICC CATHETER BASIC TRAY (5F) (TRIPLE-LUMEN) (55CM) |
Type of Device | CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS |
Manufacturer (Section D) |
C.R. BARD, INC. (BASD) -3006260740 |
605 north 5600 west |
salt lake city 84116 |
|
Manufacturer (Section G) |
BARD REYNOSA S.A. DE C.V. -9617592 |
blvd. montebello #1 |
parque industrial colonial |
reynosa, tamaulipas 88780 |
MX
88780
|
|
Manufacturer Contact |
suedabba
mahboobi
|
605 north 5600 west |
salt lake city 84116
|
8015950700
|
|
MDR Report Key | 16296581 |
MDR Text Key | 308776266 |
Report Number | 3006260740-2023-00347 |
Device Sequence Number | 1 |
Product Code |
LJS
|
Combination Product (y/n) | N |
Reporter Country Code | IN |
PMA/PMN Number | K053501 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
02/02/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/03/2023 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | N/A |
Device Catalogue Number | 8375118 |
Device Lot Number | REFT3536 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 01/17/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/01/2021 |
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) |
Required Intervention;
|