Brand Name | ULTRA THREE-WAY STOPCOCK W/SWIVEL MALE LUER LOCK |
Type of Device | FMG- STOPCOCKS AND MANIFOLDS |
Manufacturer (Section D) |
SMITHS MEDICAL, INC. |
dublin OH |
|
Manufacturer (Section G) |
SMITHS MEDICAL |
6250 shier-rings road |
|
dublin OH 43016 |
|
Manufacturer Contact |
pete
hirte
|
1265 grey fox rd. |
st. paul, MN 55112
|
6516287384
|
|
MDR Report Key | 4063104 |
MDR Text Key | 4735935 |
Report Number | 2183502-2014-00465 |
Device Sequence Number | 1 |
Product Code |
FMG
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | PREAMENDMENT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,User Facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
07/03/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 10/11/2016 |
Device Catalogue Number | MX5311L |
Device Lot Number | 2543614 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 07/03/2014 |
Device Age | 8 MO |
Event Location |
Hospital
|
Initial Date Manufacturer Received |
06/06/2014 |
Initial Date FDA Received | 07/07/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/01/2013 |
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 |