Brand Name | INSYTE CATHETER |
Type of Device | CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS |
Manufacturer (Section D) |
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. |
|
|
MDR Report Key | 11602563 |
MDR Text Key | 243639529 |
Report Number | MW5100479 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
03/30/2021 |
1 Device was Involved in the Event |
|
0 Patients were Involved in the Event: |
|
Date FDA Received | 03/31/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Expiration Date | 04/30/2021 |
Device Lot Number | 0080382 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/24/2021 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Was Device Evaluated by Manufacturer? |
|
Is the Device Single Use? |
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
|
|
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