Brand Name | UNSPECIFIED BD SECONDARY INFUSION SET |
Type of Device | INTRAVASCULAR ADMINISTRATION SET |
Manufacturer (Section D) |
BECTON DICKINSON |
1 becton drive |
franklin lakes NJ 07417 |
|
Manufacturer (Section G) |
BECTON DICKINSON |
1 becton drive |
|
franklin lakes NJ 07417 |
|
Manufacturer Contact |
katie
swenson
|
9450 south state street |
sandy, UT 84070
|
8015296192
|
|
MDR Report Key | 12913508 |
MDR Text Key | 281594673 |
Report Number | 2243072-2021-02838 |
Device Sequence Number | 1 |
Product Code |
FPA
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | UNKNOWN |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
11/04/2021 |
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 |
Other
|
Device Catalogue Number | UNKNOWN |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/02/2021 |
Initial Date FDA Received | 12/01/2021 |
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 |