Brand Name | PERIFIX CATHETER SET X20 |
Type of Device | EPIDURAL CATHETER |
Manufacturer (Section D) |
B. BRAUN MELSUNGEN AG |
carl-braun-str.1 |
melsungen 34212 |
GM 34212 |
|
Manufacturer Contact |
ludwig
schuetz, safety officer m
|
carl-braun-str.1 |
melsungen D-342-12
|
GM
D-34212
|
661712769
|
|
MDR Report Key | 4649495 |
MDR Text Key | 5597766 |
Report Number | 9610825-2015-00091 |
Device Sequence Number | 1 |
Product Code |
BSO
|
Combination Product (y/n) | N |
PMA/PMN Number | K112515 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative,company representati |
Remedial Action |
Other |
Type of Report
| Initial |
Report Date |
08/19/2015,03/04/2015 |
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 Expiration Date | 11/05/2019 |
Device Catalogue Number | PCS-S18 |
Device Lot Number | 14N05H82YQ |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/08/2015 |
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 08/19/2015 |
Distributor Facility Aware Date | 03/04/2015 |
Device Age | 4 MO |
Event Location |
Hospital
|
Date Report to Manufacturer | 08/19/2015 |
Initial Date Manufacturer Received |
03/04/2015 |
Initial Date FDA Received | 03/26/2015 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/01/2014 |
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 |
|
|