EASYTOUCH
Report
- Report Number
- 3005798905-2024-03173
- Event Type
- Malfunction
- Date Received
- April 4, 2024
- Date of Event
- April 3, 2024
- Report Date
- April 4, 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
INITIAL TREND ANALYSIS FOR LOT 62942A WAS CONDUCTED, NO MALFUNCTIONS WERE FOUND. THIS IS THE ONLY COMPLAINT FOR LOT 62942A. FURTHER INVESTIGATION WILL BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF COMPLAINT.
RETAINED LOT SAMPLES FOR SYRINGE LOT 62942A WERE TESTED FOR NEEDLE CAP COMPATIBILITY AND COMPLIANCE. NO ABNORMALITIES WERE FOUND DURING TESTING.
A WORKER FOR A NEEDLE EXCHANGE PROGRAM (HIV ALLIANCE) WHO PASSES OUT SYRINGES REPORTS A POLYBAG OF SYRINGES FROM LOT 62942A WITH THE CAPS COVERING THE CANNULAS BEING "SLIGHTLY OFF". PICTURES WERE PROVIDED SHOWING THAT THE NEEDLE CAPS WERE STILL COVERING THE NEEDLES HOWEVER THERE WAS A SLIGHT GAP BETWEEN THE BARREL AND THE BOTTOM OF THE CAP.
A WORKER FOR A NEEDLE EXCHANGE PROGRAM (HIV ALLIANCE) WHO PASSES OUT SYRINGES REPORTS A POLYBAG OF SYRINGES FROM LOT 62942A WITH THE CAPS COVERING THE CANNULAS BEING "SLIGHTLY OFF". PICTURES WERE PROVIDED SHOWING THAT THE NEEDLE CAPS WERE STILL COVERING THE NEEDLES HOWEVER THERE WAS A SLIGHT GAP BETWEEN THE BARREL AND THE BOTTOM OF THE CAP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 83880 | EASYTOUCH | SYRINGE | FMF | FEEL TECH BIO CO., LTD. | 62942A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |