Brand Name | 110" (279 CM) APPX 20.5 ML, 15 DROP PRIMARY SET W/2 MICROCLAVE®, 2 GANG 4-WAY ST |
Type of Device | STOPCOCK, I.V. SET |
Manufacturer (Section D) |
ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. |
avenida cuarzo no. 250 |
ensenada, b.cfa. 22790 |
MX 22790 |
|
Manufacturer Contact |
michael
visocnik
|
600 n. field dr. |
lake forest, IL 60045
|
2247062300
|
|
MDR Report Key | 15209703 |
MDR Text Key | 297699133 |
Report Number | 9617594-2022-00233 |
Device Sequence Number | 1 |
Product Code |
FMG
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K964435 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
07/13/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | B99078 |
Device Catalogue Number | B99078 |
Device Lot Number | UNKOWN |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
07/13/2022
|
Initial Date FDA Received | 08/11/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | NORMAL SALINE, MFR UNK |
Patient Outcome(s) |
Required Intervention;
Hospitalization;
|
Patient Age | 68 YR |
Patient Sex | Male |
|
|