Brand Name | MEDEX |
Type of Device | INTRAVENOUS EXTENSION TUBING SET |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
6250 shier rings road |
dublin OH 43016 |
|
Manufacturer (Section G) |
SMITHS MEDICAL ASD, INC. |
6250 shier rings road |
|
dublin OH 43016 |
|
Manufacturer Contact |
david
halverson
|
6000 nathan lane north |
minneapolis, MN 55442
|
|
MDR Report Key | 12291175 |
MDR Text Key | 265548411 |
Report Number | 3012307300-2021-08157 |
Device Sequence Number | 1 |
Product Code |
FPK
|
UDI-Device Identifier | 10351688507334 |
UDI-Public | 10351688507334 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
08/06/2021 |
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 Operator |
Health Professional
|
Device Model Number | MX450FL |
Device Lot Number | 4072121 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
07/29/2021 |
Initial Date FDA Received | 08/06/2021 |
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 |
N
|
Patient Sequence Number | 1 |
|
|