Brand Name | OMNICELL I.V. STATION |
Type of Device | PHARMACY COMPOUNDING DEVICE |
Manufacturer (Section D) |
OMNICELL, INC. |
51 pennwood place |
warrendale PA 15086 |
|
Manufacturer (Section G) |
OMNICELL S.R.L |
piazzale legnami 1/b edificio |
9 comprensorio gasilini |
trieste, trieste 34145 |
IT
34145
|
|
Manufacturer Contact |
david
vanella
|
500 cranberry woods drive |
cranberry twp, PA 16066
|
|
MDR Report Key | 12116461 |
MDR Text Key | 263506504 |
Report Number | 3011278888-2021-00009 |
Device Sequence Number | 1 |
Product Code |
NEP
|
UDI-Device Identifier | 08056477790007 |
UDI-Public | (01)08056477790007(11)200207 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,user f |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
07/05/2021 |
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 | i.v.STATION |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
06/17/2021 |
Initial Date FDA Received | 07/05/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |