Brand Name | MEDEX® 700 PSI THREE-WAY STOPCOCK WITH MALE LUER LOCK"OFF"HANDLE. |
Type of Device | STOPCOCK, I.V. SET |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
6000 nathan lane north |
minneapolis MN 55442 |
|
Manufacturer (Section G) |
SMITHS MEDICAL ASD INC. |
6250 shier rings road |
|
dublin OH 43016 |
|
Manufacturer Contact |
lisa
perz
|
6000 nathan lane north |
minneapolis, MN 55442
|
7633833074
|
|
MDR Report Key | 6283260 |
MDR Text Key | 65953912 |
Report Number | 3012307300-2017-00282 |
Device Sequence Number | 1 |
Product Code |
FMG
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign,other,use |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
01/04/2017 |
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 |
Nurse
|
Device Expiration Date | 04/28/2019 |
Device Catalogue Number | MX4331L |
Device Lot Number | 3192499 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
01/04/2017 |
Initial Date FDA Received | 01/27/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/23/2016 |
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 | LUER LOCKING UMBILICAL CATHETER |
Patient Outcome(s) |
Other;
Required Intervention;
|
Patient Age | 24 DA |