Brand Name | ACCESS |
Type of Device | STOPCOCK, I.V. SET |
Manufacturer (Section D) |
BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL |
parque industrial itabo, zona |
haina |
DR |
|
Manufacturer (Section G) |
BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL |
parque industrial itabo, zona |
|
haina |
DR
|
|
Manufacturer Contact |
christina
arnt
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242703198
|
|
MDR Report Key | 4207667 |
MDR Text Key | 4983388 |
Report Number | 1416980-2014-37773 |
Device Sequence Number | 1 |
Product Code |
FMG
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K932512 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
10/03/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/28/2014 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Catalogue Number | 2C8931 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 10/03/2014 |
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 |
|
|