Brand Name | BD Q-SYTE LUER ACCESS SPLIT SEPTUM |
Type of Device | INTRAVASCULAR ADMINISTRATION SET |
Manufacturer (Section D) |
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. |
periferico luis donaldo |
colosio no. 579 |
nogales |
MX |
|
Manufacturer (Section G) |
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. |
periferico luis donaldo |
colosio no. 579 |
nogales |
MX
|
|
Manufacturer Contact |
phillip
emmert
|
9450 south state street |
sandy, UT 84070
|
8015296192
|
|
MDR Report Key | 13122553 |
MDR Text Key | 285765454 |
Report Number | 9610847-2021-00629 |
Device Sequence Number | 1 |
Product Code |
FPA
|
UDI-Device Identifier | 30382903851004 |
UDI-Public | 30382903851004 |
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K013621 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
12/10/2021 |
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 |
Other
|
Device Model Number | 385100 |
Device Catalogue Number | 385100 |
Device Lot Number | 0329766 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/02/2021 |
Initial Date FDA Received | 12/30/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/03/2020 |
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 |