Brand Name | ICU MEDICAL |
Type of Device | STOPCOCK, I.V. SET |
Manufacturer (Section D) |
ICU MEDICAL, INC. |
951 calle amanecer |
san clemente CA 92673 |
|
MDR Report Key | 16013591 |
MDR Text Key | 305796270 |
Report Number | 16013591 |
Device Sequence Number | 1 |
Product Code |
FMG
|
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 |
12/13/2022,11/29/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/20/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Model Number | B1115 |
Device Catalogue Number | B1115 |
Device Lot Number | 5881552 |
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 | 12/13/2022 |
Date Report to Manufacturer | 12/20/2022 |
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|