Brand Name | INSYTE AUTOGUARD |
Type of Device | CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS |
Manufacturer (Section D) |
BECTON, DICKINSON AND COMPANY |
1 becton drive |
franklin lakes NJ 07417 |
|
MDR Report Key | 12134276 |
MDR Text Key | 260474354 |
Report Number | 12134276 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
06/25/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/08/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 381523 |
Device Catalogue Number | H4715-4 |
Device Lot Number | 0342576 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 06/25/2021 |
Event Location |
Hospital
|
Date Report to Manufacturer | 07/08/2021 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Age | 3285 DA |
Patient Weight | 26 |
|
|