Brand Name | 3000 ML TPN BAG |
Type of Device | SET, I.V. FLUID TRANSFER |
Manufacturer (Section D) |
AVAILMED |
tijuana, baja california |
|
Manufacturer (Section G) |
AVAILMED |
c. industrial lt 001 mz 105 |
no 20905 int a, col cd ind. |
tijuana, baja california 22444 |
MX
22444
|
|
Manufacturer Contact |
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242702068
|
|
MDR Report Key | 8095299 |
MDR Text Key | 128086331 |
Report Number | 1416980-2018-07395 |
Device Sequence Number | 1 |
Product Code |
LHI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K900585 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
12/19/2018 |
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 | H938741 |
Device Lot Number | 60131891 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/29/2018 |
Initial Date FDA Received | 11/21/2018 |
Supplement Dates Manufacturer Received | 11/28/2018
|
Supplement Dates FDA Received | 12/19/2018
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|