Brand Name | MICROCLAVE® NEUTRAL CONNECTOR |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
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 | 14596992 |
MDR Text Key | 301038284 |
Report Number | 9617594-2022-00154 |
Device Sequence Number | 1 |
Product Code |
FPA
|
UDI-Device Identifier | 00887709042377 |
UDI-Public | (01)00887709042377(17)270201(10)5809423 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K970855 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
05/09/2022 |
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 Model Number | 12568 |
Device Catalogue Number | 12568 |
Device Lot Number | 5809423 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/17/2022 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/09/2022 |
Initial Date FDA Received | 06/03/2022 |
Supplement Dates Manufacturer Received | 06/21/2022
|
Supplement Dates FDA Received | 07/14/2022
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/01/2022 |
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 | EXTENSION SET ITEM #12517-01, ICU MED MFR; FLUSH SYRINGE ITEM #306546, BD MFR; SYRINGE KIT ITEM #SSS-CTP-QFT, MEDRAD STELLANT MFR; UNSPECIFIED IV PRODUCT, MFR UNK |