Brand Name | INTROCAN SAFETY® |
Type of Device | INTRODUCER, CATHETER |
Manufacturer (Section D) |
B. BRAUN MELSUNGEN AG |
carl-braun-str. 1 |
melsungen, hessen 34212 |
GM 34212 |
|
Manufacturer (Section G) |
B. BRAUN MELSUNGEN AG |
carl-braun-str. 1 |
|
melsungen, hessen 34212 |
GM
34212
|
|
Manufacturer Contact |
jonathan
severino
|
861 marcon blvd. |
allentown, PA 18109
|
4842408332
|
|
MDR Report Key | 8479607 |
MDR Text Key | 140813316 |
Report Number | 9610825-2019-00092 |
Device Sequence Number | 1 |
Product Code |
DYB
|
UDI-Device Identifier | 04046963318260 |
UDI-Public | (01)04046963318260 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K021094 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
04/03/2019 |
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 | 4253574-02 |
Device Catalogue Number | 4253574-02 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 04/03/2019 |
Distributor Facility Aware Date | 03/06/2019 |
Event Location |
Hospital
|
Date Report to Manufacturer | 04/03/2019 |
Initial Date Manufacturer Received |
03/06/2019 |
Initial Date FDA Received | 04/03/2019 |
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 |
|
|