FDA Adverse Event
Malfunction
Summary report: N
EASYTOUCH
MDR report key: 19845220
·
Received July 26, 2024
Report
- Report Number
- 3005798905-2024-03194
- Event Type
- Malfunction
- Date Received
- July 26, 2024
- Date of Event
- July 15, 2024
- Report Date
- July 26, 2024
- 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 65851A WAS CONDUCTED, NO MALFUNCTIONS WERE FOUND. THIS IS THE ONLY COMPLAINT FOR LOT 65851A. FURTHER INVESTIGATION WILL BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF COMPLAINT.
Additional Manufacturer Narrative · 0
RETAINED LOT SAMPLES FOR SYRINGE LOT 65851A WERE TESTED FOR BARREL AND PLUNGER COMPATIBILITY, AND BURRS ON CANNULA TIP. NO ABNORMALITIES WERE FOUND DURING TESTING.
Description of Event or Problem · 0
END USER REPORTS THAT SYRINGES 830165 LOT 65851A ARE DULL.
Description of Event or Problem · 0
END USER REPORTS THAT SYRINGES 830165 LOT 65851A ARE DULL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 561756 | EASYTOUCH | SYRINGE | FMF | FEEL TECH BIO CO., LTD. | 68581A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |