FDA Adverse Event
Malfunction
Summary report: N
EASYTOUCH
MDR report key: 19595389
·
Received June 24, 2024
Report
- Report Number
- 3005798905-2024-03188
- Event Type
- Malfunction
- Date Received
- June 24, 2024
- Date of Event
- June 7, 2024
- Report Date
- June 24, 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
RETAINED SYRINGES FROM LOT: 64844A WERE TESTED FOR BARREL AND PLUNGER COMPATIBILITY, NO ABNORMALITIES WERE DETECTED DURING TESTING.
Additional Manufacturer Narrative · 0
INITIAL TREND ANALYSIS FOR LOT 64844A WAS CONDUCTED, NO MALFUNCTIONS WERE FOUND. THIS IS THE ONLY COMPLAINT FOR LOT 64844A. FURTHER INVESTIGATION WILL BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF COMPLAINT.
Description of Event or Problem · 0
A DIRECT CUSTOMER OF A DISTRIBUTOR REPORTED THAT THE PLUNGERS CAN EASILY BE REMOVED FROM THE BARREL OF SYRINGES 831165, LT 64844A WITHOUT MUCH FORCE.
Description of Event or Problem · 0
A DIRECT CUSTOMER OF A DISTRIBUTOR REPORTED THAT THE PLUNGERS CAN EASILY BE REMOVED FROM THE BARREL OF SYRINGES 831165 LT 64844A WITHOUT MUCH FORCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1578201 | EASYTOUCH | SYRINGE | FMF | FEEL TECH BIO CO., LTD. | 64844A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |