Brand Name | CADD® ADMINISTRATION SETS |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
6000 nathan lane north |
minneapolis MN 55442 |
|
Manufacturer (Section G) |
SMITHS HEALTHCARE MFG |
s.a. de c.v. ave calidad no. 4 |
parque industrial internaciona |
tijuana, b.c. 22425 |
MX
22425
|
|
Manufacturer Contact |
lisa
perz
|
6000 nathan lane north |
minneapolis, MN 55442
|
7633833074
|
|
MDR Report Key | 6338940 |
MDR Text Key | 67715176 |
Report Number | 3012307300-2017-00439 |
Device Sequence Number | 1 |
Product Code |
FPA
|
UDI-Device Identifier | 10610586029646 |
UDI-Public | 10610586029646 |
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K040636 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
01/23/2017 |
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 Catalogue Number | 21-7322-24 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/23/2017 |
Initial Date FDA Received | 02/17/2017 |
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 |
Unknown
|
Patient Sequence Number | 1 |
Treatment | CADD PUMP (SERIAL #(B)(4)); ICU MEDICAL ANTISIPHON VALVE B6013; ICU MEDICAL FILTER 0.2 B1371 |
Patient Outcome(s) |
Hospitalization;
Life Threatening;
Other;
Required Intervention;
|