Brand Name | POWERPICC 4F SL MAX BARRIER PLUS KIT |
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 |
kelsey
erickson
|
605 north 5600 west |
salt lake city 84116
|
8015950700
|
|
MDR Report Key | 11609429 |
MDR Text Key | 243831026 |
Report Number | 3006260740-2021-01114 |
Device Sequence Number | 1 |
Product Code |
LJS
|
UDI-Device Identifier | 00801741155048 |
UDI-Public | (01)00801741155048 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K070996 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,other |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
03/12/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/02/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | N/A |
Device Catalogue Number | 1174108D4 |
Device Lot Number | REEN3298 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 03/10/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/01/2020 |
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) |
Other;
|
Patient Age | 73 YR |