EASYTOUCH
Report
- Report Number
- 3005798905-2023-03124
- Event Type
- Malfunction
- Date Received
- June 28, 2023
- Date of Event
- June 27, 2023
- Report Date
- June 28, 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 58214A FOR SUCTION AND PLUNGER BARREL SUITABILITY, NO ABNORMALITIES WERE FOUND DURING TESTING.
PRODUCTION RECORDS INVESTIGATED FOR LOT NUMBER 58214A. THE TESTING SHOWED NO INDICATION OF ABNORMALITIES OR MALFUNCTION AT TIME OF PRODUCTION.
END USER REPORTS THAT USING INSULIN SYRINGES ITEM 830165 LOT 58214A, THE PLUNGER OF THE SYRINGES HAVE A WEAK SUCTION, EASILY DRAWING IN AIR INTO THE BARREL AND THE PLUNGER IS EASY TO REMOVE WITHOUT RESISTANCE. THE USER DID NOT WISH TO DISCLOSE THE TYPE OF MEDICATION BEING USED WITH THE SYRINGES, NOR DID HE VERIFY THAT THE MEDICATION VIAL WAS BEING DEPRESSURIZED PRIOR TO PULLING MEDICINE WITH THE SYRINGE.
END USER REPORTS THAT USING INSULIN SYRINGES ITEM 830165 LOT 58214A, THE PLUNGER OF THE SYRINGES HAVE A WEAK SUCTION, EASILY DRAWING IN AIR INTO THE BARREL AND THE PLUNGER IS EASY TO REMOVE WITHOUT RESISTANCE. THE USER DID NOT WISH TO DISCLOSE THE TYPE OF MEDICATION BEING USED WITH THE SYRINGES, NOR DID HE VERIFY THAT THE MEDICATION VIAL WAS BEING DEPRESSURIZED PRIOR TO PULLING MEDICINE WITH THE SYRINGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1783228 | EASYTOUCH | INSULIN SYRINGE | FMF | FEEL TECH BIO CO., LTD. | 58214A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |