Brand Name | ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP |
Type of Device | IV ADMINISTRATION SET |
Manufacturer (Section D) |
ZYNO MEDICAL LLC |
177 pine street |
natick MA 01760 |
|
Manufacturer (Section G) |
ZYNO MEDICAL, LLC |
177 pine street |
|
natick MA 01760 |
|
Manufacturer Contact |
chaoyoung
lee
|
177 pine street |
natick, MA 01760
|
5086502008
|
|
MDR Report Key | 6234090 |
MDR Text Key | 64242907 |
Report Number | 3006575795-2016-00148 |
Device Sequence Number | 1 |
Product Code |
FPA
|
UDI-Device Identifier | 00814371020112 |
UDI-Public | 00814371020112 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K132841 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
01/09/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/09/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 01/01/2017 |
Device Model Number | A2-80072 |
Device Lot Number | 1410015 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/23/2016 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 03/23/2016 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/01/2014 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |