Brand Name | JOEY 1000ML PUMP SET |
Type of Device | PUMP, INFUSION, ENTERAL |
Manufacturer (Section D) |
CARDINAL HEALTH |
777 west street |
mansfield MA 02048 |
|
Manufacturer (Section G) |
CARDINAL HEALTH |
777 west street |
|
mansfield MA 02048 |
|
Manufacturer Contact |
jill
saraiva
|
777 west street |
mansfield, MA 02048
|
5086183640
|
|
MDR Report Key | 13893162 |
MDR Text Key | 288047028 |
Report Number | 1282497-2022-10683 |
Device Sequence Number | 1 |
Product Code |
LZH
|
UDI-Device Identifier | 10884521072305 |
UDI-Public | 10884521072305 |
Combination Product (y/n) | N |
Reporter Country Code | CA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,User Facility,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
05/26/2022 |
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 Model Number | 763656 |
Device Catalogue Number | 763656 |
Device Lot Number | 210810122 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
03/23/2022 |
Initial Date FDA Received | 03/24/2022 |
Supplement Dates Manufacturer Received | 03/23/2022
|
Supplement Dates FDA Received | 05/26/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|