Brand Name | GEM V/NV 20DP CKV 2SS 0.2MF LOW SORBING |
Type of Device | INTRAVENOUS EXTENSION TUBING SET |
Manufacturer (Section D) |
BECTON DICKINSON |
1 becton drive |
franklin lakes NJ 07417 |
|
Manufacturer (Section G) |
BECTON DICKINSON, S.A. |
camino de valdeolivia |
s/n |
san agustin de guadalix |
|
Manufacturer Contact |
helen
cox (mdr)
|
75 north fairway drive |
vernon hills, IL 60061
|
8473935694
|
|
MDR Report Key | 18969539 |
MDR Text Key | 338595385 |
Report Number | 9616066-2024-00461 |
Device Sequence Number | 1 |
Product Code |
FPA
|
UDI-Device Identifier | 10885403232343 |
UDI-Public | (01)10885403232343 |
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K022209 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
03/07/2024 |
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 | 11532269 |
Device Lot Number | 23115345 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/28/2024
|
Initial Date FDA Received | 03/25/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/07/2022 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |