Brand Name | 22 CM (8.5") EXT SET W/0.2 MICRON FILTER, CLAMP, 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 |
reed
covert
|
600 n. field dr. |
lake forest, IL 60045
|
2247062300
|
|
MDR Report Key | 18992414 |
MDR Text Key | 339257273 |
Report Number | 9617594-2024-00345 |
Device Sequence Number | 1 |
Product Code |
FMG
|
Combination Product (y/n) | N |
Reporter Country Code | TW |
PMA/PMN Number | K964435 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative,Distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/28/2024 |
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-C32029 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/14/2024 |
Initial Date Manufacturer Received |
02/27/2024
|
Initial Date FDA Received | 03/28/2024 |
Was Device Evaluated by Manufacturer? |
Yes
|
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 CHEMO SOLUTION, MFR UNK |
|
|