Brand Name | ACCESS |
Type of Device | SET, BLOOD TRANSFUSION |
Manufacturer (Section D) |
BAXTER HEALTHCARE - MALTA |
a47 industrial estate |
malta b |
marsa |
MT |
|
Manufacturer (Section G) |
BAXTER HEALTHCARE - MALTA |
a47 industrial estate |
malta b |
marsa |
MT
|
|
Manufacturer Contact |
kinga
almasan
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242702068
|
|
MDR Report Key | 4609003 |
MDR Text Key | 20458282 |
Report Number | 1416980-2015-11389 |
Device Sequence Number | 1 |
Product Code |
BRZ
|
Combination Product (y/n) | N |
Reporter Country Code | BE |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Pharmacist
|
Type of Report
| Initial |
Report Date |
02/20/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/17/2015 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Expiration Date | 10/31/2019 |
Device Catalogue Number | RMC9622P |
Device Lot Number | 14K15V582 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/13/2015 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 02/20/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/10/2014 |
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 |