Brand Name | 32 CM (13") EXT SET W/4-WAY STOPCOCK, CHECK VALVE, ROTATING LUER |
Type of Device | STOPCOCK, I.V. 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 |
|
Manufacturer Contact |
michael
visocnik
|
600 n. field dr. |
lake forest, IL 60045
|
2247062300
|
|
MDR Report Key | 15433531 |
MDR Text Key | 306265164 |
Report Number | 9617594-2022-00275 |
Device Sequence Number | 1 |
Product Code |
FMG
|
UDI-Device Identifier | 00840619027117 |
UDI-Public | (01)00840619027117(17)261101(10)5679660 |
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K964435 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Pharmacist
|
Type of Report
| Initial,Followup |
Report Date |
08/17/2022 |
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 Catalogue Number | 011-H3745 |
Device Lot Number | 5679660 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/17/2022 |
Initial Date FDA Received | 09/15/2022 |
Supplement Dates Manufacturer Received | 11/10/2022
|
Supplement Dates FDA Received | 12/09/2022
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/01/2021 |
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 |
Treatment | UNSPECIFIED CHEMOTHERAPY, MFR UNK |
|
|