Brand Name | SMALLBORE EXTENSION SET |
Type of Device | SET, EXTENSION, INTRAVASCULAR |
Manufacturer (Section D) |
CAREFUSION |
10020 pacific mesa blvd |
san diego CA 92121 4386 |
|
Manufacturer (Section G) |
CAREFUSION |
10020 pacific mesa blvd |
|
san diego CA 92121 4386 |
|
Manufacturer Contact |
ade
ajibade
|
10020 pacific mesa blvd |
san diego, CA 92121-4386
|
8586172000
|
|
MDR Report Key | 7042611 |
MDR Text Key | 92364265 |
Report Number | 9616066-2017-01493 |
Device Sequence Number | 1 |
Product Code |
FPA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K061285 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
10/25/2017 |
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 |
Health Professional
|
Device Model Number | 20041E |
Device Catalogue Number | 20041E |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/25/2017 |
Initial Date FDA Received | 11/17/2017 |
Was Device Evaluated by Manufacturer? |
No
|
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) |
Other;
|
|
|