EASYTOUCH
Report
- Report Number
- 3005798905-2023-03148
- Event Type
- Malfunction
- Date Received
- November 20, 2023
- Date of Event
- November 15, 2023
- Report Date
- November 20, 2023
- Manufacturer
- FEEL TECH BIO CO., LTD.
- Product Code
- FMF
- PMA / PMN Number
- K102178
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- 003
Narratives
CMO INSPECTED RETAINED LOT 60702A, NO ABNORMALITIES WERE FOUND DURING TESTING.
INITIAL TREND ANALYSIS FOR LOT 60702A WAS CONDUCTED, NO MALFUNCTIONS WERE FOUND. THIS IS THE ONLY COMPLAINT FOR LOT 60702A. FURTHER INVESTIGATION WILL BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF COMPLAINT.
END USER REPORTS THAT THE SYRINGE FROM LOT 60702A ARE DIFFERENT IN APPEARANCE THAN SYRINGES PURCHASED IN THE PAST. USER DESCRIBES THE PLUNGER IS EASILY REMOVED FROM THE BARREL,THE CANNULA IS DULL AND THE END CAPS DO NOT FIT PROPERLY WHICH CAUSED A FEW CAPS TO FALL OFF INSIDE OF THE POLYBAG. END USER DID NOT COMMUNICATE AFTER SEVERAL ATTEMPTS AS TO WHICH SIDE OF THE SYRINGE THE CAP WAS OFF INSIDE OF THE POLYBAG.
END USER REPORTS THAT THE SYRINGE FROM LOT 60702A ARE DIFFERENT IN APPEARANCE THAN SYRINGES PURCHASED IN THE PAST. USER DESCRIBES THE PLUNGER IS EASILY REMOVED FROM THE BARREL,THE CANNULA IS DULL AND THE END CAPS DO NOT FIT PROPERLY WHICH CAUSED A FEW CAPS TO FALL OFF INSIDE OF THE POLYBAG. END USER DID NOT COMMUNICATE AFTER SEVERAL ATTEMPTS AS TO WHICH SIDE OF THE SYRINGE THE CAP WAS OFF INSIDE OF THE POLYBAG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1855446 | EASYTOUCH | INSULIN SYRINGE | FMF | FEEL TECH BIO CO., LTD. | 60702A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |