Brand Name | JELCO® PROTECTIV® SAFETY I.V. CATHETERS |
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 55442 |
|
Manufacturer (Section G) |
SMITHS MEDICAL NORTH AMERICA, |
201 west queen street |
|
southington CT 06489 |
|
Manufacturer Contact |
dave
halverson
|
6000 nathan lane n |
minneapolis,, MN 55442
|
7633833310
|
|
MDR Report Key | 9709051 |
MDR Text Key | 179436476 |
Report Number | 3012307300-2020-01093 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
02/13/2020 |
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? |
Yes
|
Device Operator |
No Information
|
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
01/14/2020 |
Initial Date FDA Received | 02/13/2020 |
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;
|
|
|