Brand Name | VENTED HIGH VOL. INLET, N/S |
Type of Device | SET, I.V. FLUID TRANSFER |
Manufacturer (Section D) |
BAXTER HEALTHCARE CORPORATION |
deerfield IL |
|
Manufacturer (Section G) |
PLASTICOS Y MATERIAS PRIMAS PYMPSA |
3609-2 juan de la barrera |
parque industrial el alamo |
guadalajara, jalisco 44490 |
MX
44490
|
|
Manufacturer Contact |
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242702068
|
|
MDR Report Key | 17905799 |
MDR Text Key | 325710960 |
Report Number | 1416980-2023-05127 |
Device Sequence Number | 1 |
Product Code |
LHI
|
UDI-Device Identifier | 00085412475790 |
UDI-Public | (01)00085412475790 |
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K002705 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
11/08/2023 |
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 Catalogue Number | H938174 |
Device Lot Number | 803542 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
09/14/2023 |
Initial Date FDA Received | 10/10/2023 |
Supplement Dates Manufacturer Received | 11/06/2023
|
Supplement Dates FDA Received | 11/08/2023
|
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 |
Treatment | NA. |
|
|