Brand Name | BEACON TIP ROYAL FLUSH PLUS FLUSH CATHETER |
Type of Device | DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC |
Manufacturer (Section D) |
COOK, INC. |
bloomington IN 47404 |
|
Manufacturer Contact |
rita
harden, director
|
750 daniels way |
bloomington, IN 47404
|
8123392235
|
|
MDR Report Key | 3818111 |
MDR Text Key | 4500478 |
Report Number | 1820334-2014-00217 |
Device Sequence Number | 1 |
Product Code |
DQO
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility |
Reporter Occupation |
Unknown
|
Type of Report
| Initial |
Report Date |
04/24/2014 |
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 Expiration Date | 02/28/2017 |
Device Catalogue Number | HNR4.0-35-65-P-8S-VCF |
Device Lot Number | 4781832 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 04/10/2014 |
Device Age | 2 MO |
Event Location |
Hospital
|
Initial Date Manufacturer Received |
04/28/2014 |
Initial Date FDA Received | 05/13/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/17/2014 |
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;
|
|
|