Brand Name | ICU MEDICAL |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
ICU MEDICAL, INC. |
951 calle amanecer |
san clemente CA 92673 |
|
MDR Report Key | 17236980 |
MDR Text Key | 318215180 |
Report Number | 17236980 |
Device Sequence Number | 1 |
Product Code |
FPA
|
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 |
06/14/2023 |
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 Model Number | 14018-04 |
Device Catalogue Number | 14018-04 |
Device Lot Number | 13493394, 13493364, 13474117, |
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 | 06/14/2023 |
Date Report to Manufacturer | 06/30/2023 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 06/30/2023 |
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|