Brand Name | SMALLBORE EXT SET W/MICROCLAVE CLEAR, CLAMP, ROTATING LUER |
Type of Device | SMALLBORE EXT SET W/MICROCLAVE CLEAR, CLAMP, ROTATING LUER |
Manufacturer (Section D) |
ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. |
avenida cuarzo no. 250 |
colonia rancho santa clara, ma |
ensenada, 22790 |
MX 22790 |
|
MDR Report Key | 8066623 |
MDR Text Key | 128419039 |
Report Number | 9617594-2018-00155 |
Device Sequence Number | 1 |
Product Code |
FMG
|
UDI-Device Identifier | 00887709037267 |
UDI-Public | 887709037267 |
Combination Product (y/n) | N |
PMA/PMN Number | K964435 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign,health pr |
Type of Report
| Initial,Followup |
Report Date |
10/24/2018 |
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 Expiration Date | 06/01/2023 |
Device Model Number | MC3302 |
Device Catalogue Number | MC3302 |
Device Lot Number | 3710736 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/16/2018 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 11/13/2018 |
Supplement Dates Manufacturer Received | 11/29/2018
|
Supplement Dates FDA Received | 12/13/2018
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|