Brand Name | MICROCLAVE® CLEAR 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 |
christopher
zanoni
|
600 n. field dr. |
lake forest, IL 60045
|
2247062300
|
|
MDR Report Key | 9444465 |
MDR Text Key | 170057854 |
Report Number | 9617594-2019-00418 |
Device Sequence Number | 1 |
Product Code |
FPA
|
Combination Product (y/n) | N |
Reporter Country Code | SZ |
PMA/PMN Number | K100434 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
11/20/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 011-MC100 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
11/20/2019 |
Initial Date FDA Received | 12/10/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 | PICC LINE, UNK MFR |
Patient Outcome(s) |
Death;
Hospitalization;
Required Intervention;
|
Patient Age | 65 YR |
|
|