Brand Name | BD ALARIS PUMP MODULE SMARTSITE INFUSION SET |
Type of Device | INTRAVASCULAR ADMINISTRATION SET |
Manufacturer (Section D) |
SISTEMAS MEDICOS ALARIS S.A. DE C.V. |
blvd. insurgentes no. 20351 |
parque industrial el florido |
tijuana |
|
Manufacturer (Section G) |
SISTEMAS MEDICOS ALARIS, S.A. DE C.V. |
blvd. insurgentes no. 20351 |
parque industrial el florido |
tijuana |
|
Manufacturer Contact |
helen
cox (mdr)
|
75 north fairway drive |
vernon hills, IL 60061
|
8473935694
|
|
MDR Report Key | 19001817 |
MDR Text Key | 339051409 |
Report Number | 9616066-2024-00491 |
Device Sequence Number | 1 |
Product Code |
FPA
|
UDI-Device Identifier | 10885403227998 |
UDI-Public | (01)10885403227998 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K221327 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
03/11/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/29/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Catalogue Number | 2426-0007 |
Device Lot Number | 24015455 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 03/06/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/20/2024 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |