Brand Name | BD INSYTE AUTOGUARD |
Type of Device | CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS |
Manufacturer (Section D) |
BECTON, DICKINSON AND COMPANY |
one becton drive |
franklin lakes NJ 07417 |
|
MDR Report Key | 15274649 |
MDR Text Key | 298407083 |
Report Number | 15274649 |
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 |
Nurse
|
Type of Report
| Initial |
Report Date |
08/17/2022 |
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 Model Number | 382534 |
Device Catalogue Number | 382534 |
Device Lot Number | 2101813 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 08/17/2022 |
Event Location |
Hospital
|
Date Report to Manufacturer | 08/23/2022 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 08/23/2022 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Age | 26645 DA |
Patient Sex | Male |
Patient Weight | 51 KG |
|
|