Brand Name | IVT DISPOSABLE |
Type of Device | SET, I.V. FLUID TRANSFER |
Manufacturer (Section D) |
BAXTER HEALTHCARE - CLEVELAND |
911 highway 61 north po box 1 |
cleveland MS 38732 |
|
Manufacturer (Section G) |
BAXTER HEALTHCARE - CLEVELAND |
911 highway 61 north po box 1 |
|
cleveland MS 38732 |
|
Manufacturer Contact |
christina
arnt
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242703198
|
|
MDR Report Key | 3849743 |
MDR Text Key | 4681433 |
Report Number | 1416980-2014-17931 |
Device Sequence Number | 1 |
Product Code |
LHI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K973654 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
05/13/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/04/2014 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 01/10/2019 |
Device Catalogue Number | 2B8071 |
Device Lot Number | GR14A10035 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 09/11/2014 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 01/30/2014 |
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 |
|
|