Brand Name | MEDEX KIDS KIT CLOSED BLOOD SAMPLING SYSTEM, 19 INCH |
Type of Device | TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
6250 shier rings road |
dublin OH 43016 |
|
Manufacturer Contact |
reed
covert
|
6000 nathan lane north |
minneapolis, MN 55442
|
2247062300
|
|
MDR Report Key | 18907235 |
MDR Text Key | 337701057 |
Report Number | 1526863-2024-00012 |
Device Sequence Number | 1 |
Product Code |
DRS
|
UDI-Device Identifier | 10351688507853 |
UDI-Public | (01)10351688507853(17)260626(10)4411239 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K172458 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial,Followup |
Report Date |
04/16/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/14/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | MX4133 |
Device Lot Number | 4411239 |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 02/29/2024 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 03/20/2024 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/03/2023 |
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 |
|
|