Brand Name | CADD® HIGH-VOLUME 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 MANUFACTURING |
s.a. de c.v. |
a d no.4 parque industrial int |
tijuana, b.c. 22425 |
MX
22425
|
|
Manufacturer Contact |
dave
halverson
|
6000 nathan lane n |
minneapolis, MN 55442
|
7633833310
|
|
MDR Report Key | 7205600 |
MDR Text Key | 97738042 |
Report Number | 3012307300-2018-00139 |
Device Sequence Number | 1 |
Product Code |
FPA
|
UDI-Device Identifier | 10610586027376 |
UDI-Public | 10610586027376 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K031361 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
01/19/2018 |
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? |
No
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 06/15/2022 |
Device Catalogue Number | 21-7355-24 |
Device Lot Number | 27X192 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
01/02/2018 |
Initial Date FDA Received | 01/19/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/28/2017 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | MW5073699 |
Patient Sequence Number | 1 |
Treatment | NORMAL SALINE 2L BOLUS |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 36 YR |
Patient Weight | 70 |