Brand Name | 14" EXT SET W/0.2 MICRON FILTER, CLAVE CLEAR, CLAMP, ROTATING LUER |
Type of Device | PRIMARY IV SET |
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 | 10537462 |
MDR Text Key | 208556501 |
Report Number | 9617594-2020-00402 |
Device Sequence Number | 1 |
Product Code |
FMG
|
UDI-Device Identifier | 00887709039391 |
UDI-Public | (01)00887709039391(17)250401(10)4799806 |
Combination Product (y/n) | N |
PMA/PMN Number | K964435 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Source Type |
user facility |
Type of Report
| Initial,Followup |
Report Date |
08/19/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/15/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | MC9013 |
Device Catalogue Number | MC9013 |
Device Lot Number | 4799806 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 09/23/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | UNSPECIFIED CHEMOTHERAPY DRUG, MFR UNK |
|
|