Brand Name | BD 1ML SYRINGE LUER-LOK TIP |
Type of Device | PISTON SYRINGE |
Manufacturer (Section D) |
BECTON DICKINSON MEDICAL SYSTEMS |
route 7 and grace way |
canaan CT 06018 |
|
Manufacturer (Section G) |
BECTON DICKINSON MEDICAL SYSTEMS |
route 7 and grace way |
|
canaan CT 06018 |
|
Manufacturer Contact |
katie
swenson
|
9450 south state street |
sandy, UT 84070
|
8015296192
|
|
MDR Report Key | 12200531 |
MDR Text Key | 262676225 |
Report Number | 1213809-2021-00503 |
Device Sequence Number | 1 |
Product Code |
FMF
|
UDI-Device Identifier | 30382903096283 |
UDI-Public | 30382903096283 |
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K941562 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,other,user facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
07/07/2021 |
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 Model Number | 309628 |
Device Catalogue Number | 309628 |
Device Lot Number | 1039878 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/22/2021 |
Initial Date FDA Received | 07/20/2021 |
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 |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|