Brand Name | MICROCLAVE NEUTRAL CONNECTOR |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. |
avenida cuarzo no. 250 |
ensenada, b.cfa. 22790 |
MX 22790 |
|
MDR Report Key | 10830142 |
MDR Text Key | 216164024 |
Report Number | 9617594-2020-00484 |
Device Sequence Number | 1 |
Product Code |
FPA
|
Combination Product (y/n) | N |
PMA/PMN Number | K100434 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,health profession |
Type of Report
| Initial,Followup |
Report Date |
10/23/2020 |
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 | B3300 |
Device Catalogue Number | B3300 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
10/23/2020 |
Initial Date FDA Received | 11/12/2020 |
Supplement Dates Manufacturer Received | 11/30/2020
|
Supplement Dates FDA Received | 12/01/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|