Brand Name | INTROCAN® SAFETY |
Type of Device | I.V. SAFETY 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, 34212 |
GM
34212
|
|
Manufacturer Contact |
jonathan
severino
|
200 boulder dr. |
breinigsville, PA 18031
|
4842408332
|
|
MDR Report Key | 6777849 |
MDR Text Key | 82187922 |
Report Number | 9610825-2017-00163 |
Device Sequence Number | 1 |
Product Code |
DQR
|
Combination Product (y/n) | N |
Reporter Country Code | BR |
PMA/PMN Number | K982805 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
01/04/2018 |
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 | N/A |
Device Catalogue Number | 4251679-04 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/17/2017 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 01/04/2018 |
Event Location |
Hospital
|
Date Report to Manufacturer | 01/04/2018 |
Initial Date Manufacturer Received |
07/13/2017 |
Initial Date FDA Received | 08/09/2017 |
Supplement Dates Manufacturer Received | 07/13/2017
|
Supplement Dates FDA Received | 01/04/2018
|
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 |
|
|