Brand Name | ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP |
Type of Device | IV ADMINISTRATION SET |
Manufacturer (Section D) |
INFUTRONIX, LLC |
177 pine street |
natick MA 01760 |
|
Manufacturer (Section G) |
INFUTRONIX, LLC |
177 pine street |
|
natick MA 01760 |
|
Manufacturer Contact |
chaoyung
lee
|
177 pine street |
natick, MA 01760
|
5086502007
|
|
MDR Report Key | 18121546 |
MDR Text Key | 327946838 |
Report Number | 3011581906-2023-00289 |
Device Sequence Number | 1 |
Product Code |
FPA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K153193 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
11/13/2023 |
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 |
Lay User/Patient
|
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
11/01/2023
|
Initial Date FDA Received | 11/13/2023 |
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 |
Unknown
|
Patient Sequence Number | 1 |
Patient Age | 70 YR |
Patient Sex | Male |
|
|