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
|
5083158202
|
|
MDR Report Key | 7542026 |
MDR Text Key | 109637694 |
Report Number | 3006575795-2018-00043 |
Device Sequence Number | 1 |
Product Code |
FPA
|
UDI-Device Identifier | 00814371020075 |
UDI-Public | 00814371020075 |
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,user faci |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
05/10/2018 |
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 |
Health Professional
|
Device Model Number | A2-80071-DF |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
05/10/2018 |
Initial Date FDA Received | 05/24/2018 |
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 |
Initial
|
Patient Sequence Number | 1 |