Brand Name | POWERPICC SOLO 4F SINGLE-LUMEN CATHETER FULL TRAY (WITH MICROINTRODUCER) |
Type of Device | CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS |
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. -9617592 |
blvd. montebello #1 |
parque industrial colonial |
reynosa, tamaulipas |
MX
|
|
Manufacturer Contact |
kayla
olsen
|
605 n. 5600 w. |
salt lake city, UT 84116
|
8015225010
|
|
MDR Report Key | 10049696 |
MDR Text Key | 190780035 |
Report Number | 3006260740-2020-01716 |
Device Sequence Number | 1 |
Product Code |
LJS
|
UDI-Device Identifier | 00801741139048 |
UDI-Public | (01)00801741139048 |
Combination Product (y/n) | N |
Reporter Country Code | BE |
PMA/PMN Number | K072230 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
05/12/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 6194108 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Event Location |
Hospital
|
Initial Date Manufacturer Received |
04/20/2020 |
Initial Date FDA Received | 05/12/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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) |
Hospitalization;
Life Threatening;
Required Intervention;
|