Brand Name | CENTRAL VENOUS CATHETER KIT, HEPARIN COATED |
Type of Device | CATHETER, INTRAVASCULAR, THERAPEUTIC |
Manufacturer (Section D) |
ICU MEDICAL, INC. |
lake forest IL |
|
MDR Report Key | 9417819 |
MDR Text Key | 169512696 |
Report Number | MW5091462 |
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 |
Voluntary
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
12/02/2019 |
3 Devices were Involved in the Event: |
1
2
3
|
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 Catalogue Number | 414010423 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/29/2019 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 12/04/2019 |
Was Device Evaluated by Manufacturer? |
No Information
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|