Brand Name | JELCO SAF-T HOLDER MULTI SAMPLE LUER A |
Type of Device | TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COL |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
10 bowman dr. |
keene NH 03431 |
|
Manufacturer (Section G) |
SMITHS MEDICAL ASD, INC. |
10 bowman dr. |
|
keene NH 03431 |
|
Manufacturer Contact |
jim
vegel
|
6000 nathan lane north |
minneapolis, MN 55442
|
|
MDR Report Key | 15277661 |
MDR Text Key | 304987386 |
Report Number | 3012307300-2022-15906 |
Device Sequence Number | 1 |
Product Code |
JKA
|
UDI-Device Identifier | 20351688062953 |
UDI-Public | 20351688062953 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K923090 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
08/23/2022 |
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 | 96000 |
Device Catalogue Number | 96000 |
Device Lot Number | 3889167 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/22/2020 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
04/20/2022 |
Initial Date FDA Received | 08/23/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/22/2019 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |