Brand Name | INTROCAN SAFETY® |
Type of Device | I.V. SAFETY CATHETER, |
Manufacturer (Section D) |
B. BRAUN MELSUNGEN AG |
carl-braun str.1 |
melsungen, 34212 |
GM 34212 |
|
Manufacturer (Section G) |
B. BRAUN MELSUNGEN AG |
carl-braun str.1 |
|
melsungen, 34212 |
GM
34212
|
|
Manufacturer Contact |
ludwig
schuetz
|
b. braun melsungen ag |
carl-braun str. 1 |
melsungen, 34212
|
GM
34212
|
661712769
|
|
MDR Report Key | 6042365 |
MDR Text Key | 57936128 |
Report Number | 9610825-2016-00655 |
Device Sequence Number | 1 |
Product Code |
DQR
|
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 |
distributor,health profession |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
10/19/2016,09/23/2016 |
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 Catalogue Number | 4251687-02 |
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 | 10/19/2016 |
Distributor Facility Aware Date | 09/23/2016 |
Event Location |
Other
|
Date Report to Manufacturer | 10/19/2016 |
Initial Date Manufacturer Received |
09/23/2016 |
Initial Date FDA Received | 10/19/2016 |
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 |
|
|