Brand Name | BD¿ ARTERIAL CANNULA WITH BD FLOWSWITCH¿ 20G X 45MM |
Type of Device | ARTERIAL CANNULA |
Manufacturer (Section D) |
BECTON DICKINSON MEDICAL (SINGAPORE) |
30 tuas avenue 2 |
singapore |
|
Manufacturer (Section G) |
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. |
9450 south state street |
|
sandy UT 84070 |
|
Manufacturer Contact |
brett
wilko
|
9450 south state street |
sandy, UT 84070
|
8015652845
|
|
MDR Report Key | 6122110 |
MDR Text Key | 60747418 |
Report Number | 8041187-2016-00080 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | N/A |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,other,user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
11/16/2016 |
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? |
Yes
|
Device Operator |
Other
|
Device Catalogue Number | 682245 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
11/03/2016 |
Initial Date FDA Received | 11/22/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|