Brand Name | LEONARD 10 FR DL CVC, PEEL-APART INTRODUCER KIT |
Manufacturer (Section D) |
BARD ACCESS SYSTEMS INC. |
salt lake city UT |
|
Manufacturer (Section G) |
BARD REYNOSA S.A. DE C.V. |
blvd. montebello #1 |
parque industrial colonial |
reynosa, tamaulipas |
MX
|
|
Manufacturer Contact |
christy
chandonia
|
605 north 5600 west |
salt lake city, UT 84116-0000
|
8015224969
|
|
MDR Report Key | 4173537 |
MDR Text Key | 5091846 |
Report Number | 3006260740-2014-00509 |
Device Sequence Number | 1 |
Product Code |
LJS
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K830233 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
09/15/2014 |
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 Catalogue Number | 7617405 |
Device Lot Number | REXG2001 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/01/2014 |
Is the Reporter a Health Professional? |
Yes
|
Event Location |
Hospital
|
Initial Date Manufacturer Received |
09/18/2014
|
Initial Date FDA Received | 10/10/2014 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 07/01/2013 |
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;
|
|
|