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 |
larry
pool, mgr
|
750 daniels way |
bloomington, IN 47404
|
8123362235
|
|
MDR Report Key | 4707594 |
MDR Text Key | 16178569 |
Report Number | 1820334-2015-00193 |
Device Sequence Number | 1 |
Product Code |
DQO
|
Combination Product (y/n) | N |
Reporter Country Code | AS |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/16/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/16/2015 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 10/01/2016 |
Device Catalogue Number | HNR4.0-35-70-P-10S-PIG |
Device Lot Number | 4539617 |
Other Device ID Number | (01)00827002094062(17)161001(1 |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 03/31/2015 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 03/13/2015 |
Device Age | 17 MO |
Event Location |
Hospital
|
Date Manufacturer Received | 03/16/2015 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 10/01/2013 |
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;
|
|
|