Brand Name | 32" (81 CM) APPX 6.3 ML, 15 DROP ADMIN SET W/0.2 MICRON FILTER, ROTATING LUER W/ |
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 | 17645511 |
MDR Text Key | 322215872 |
Report Number | 9617594-2023-00608 |
Device Sequence Number | 1 |
Product Code |
FMG
|
UDI-Device Identifier | 00887709055445 |
UDI-Public | (01)00887709055445(17)270901(10)9930806 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K964435 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Administrator/Supervisor
|
Type of Report
| Initial |
Report Date |
08/04/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/29/2023 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | B30183 |
Device Lot Number | 9930806 |
Date Manufacturer Received | 08/04/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/01/2022 |
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 | ETOPOSIDE, UNK MFR; PLUM 360 (V 15.X), ICU MEDICAL |
|
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