Brand Name | BD INSYTE AUTOGUARD |
Type of Device | CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS |
Manufacturer (Section D) |
BECTON, DICKINSON AND COMPANY |
9450 s state street |
sandy UT 84070 |
|
MDR Report Key | 6830597 |
MDR Text Key | 83984011 |
Report Number | 6830597 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
07/31/2017,08/01/2017 |
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 |
No Information
|
Device Expiration Date | 11/30/2019 |
Device Catalogue Number | 382523 |
Device Lot Number | 6357802 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/01/2017 |
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 07/31/2017 |
Event Location |
Hospital
|
Date Report to Manufacturer | 07/31/2017 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 08/30/2017 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|