FDA Adverse Event
Malfunction
Summary report: N
EASYTOUCH
MDR report key: 17471905
·
Received August 7, 2023
Report
- Report Number
- 3005798905-2023-03131
- Event Type
- Malfunction
- Date Received
- August 7, 2023
- Date of Event
- August 4, 2023
- Report Date
- August 7, 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
Additional Manufacturer Narrative · 0
INITIAL TREND ANALYSIS FOR LOT 59363C WAS CONDUCTED, NO MALFUNCTIONS WERE FOUND. THIS IS THE ONLY COMPLAINT FOR LOT 59363C. FURTHER INVESTIGATION WILL BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF COMPLAINT.
Additional Manufacturer Narrative · 0
CMO INSPECTED RETAINED LOT 59363C FOR NEEDLE SHARPNESS, NO ABNORMALITIES WERE FOUND DURING TESTING.
Description of Event or Problem · 0
END USER REPORTS THAT THE SYRINGES 831365 LOT 59363C ARE ALMOST TOO DULL TO PENETRATE THE NOVALOG INSULIN VIAL PRIOR TO USE.
Description of Event or Problem · 0
END USER REPORTS THAT THE SYRINGES 831365 LOT 59363C ARE ALMOST TOO DULL TO PENETRATE THE NOVALOG INSULIN VIAL PRIOR TO USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1338079 | EASYTOUCH | SYRINGES | FMF | FEEL TECH BIO CO., LTD. | 59363C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |