Brand Name | JELCO VIAVALVE SAFETY IV CATHETER |
Type of Device | CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS |
Manufacturer (Section D) |
SMITHS MEDICAL ASD; INC. |
6000 nathan lane n |
minneapolis, mn |
|
Manufacturer (Section G) |
SMITHS MEDICAL ASD; INC |
201 west queen street, |
|
southington, ct |
|
Manufacturer Contact |
dave
halverson
|
6000 nathan lane n |
minneapolis, mn
|
3833310
|
|
MDR Report Key | 10074303 |
MDR Text Key | 191533529 |
Report Number | 3012307300-2020-04184 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
UDI-Device Identifier | 10351688077431 |
UDI-Public | 10351688077431 |
Combination Product (y/n) | N |
Reporter Country Code | IT |
PMA/PMN Number | K113700 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
05/19/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/20/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 326600 |
Device Catalogue Number | 326600 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 04/19/2020 |
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 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 1 DA |
|
|