EASY TOUCH
Report
- Report Number
- 3005798905-2022-03063
- Event Type
- Malfunction
- Date Received
- June 6, 2022
- Date of Event
- June 3, 2022
- Report Date
- June 6, 2022
- Manufacturer
- MHC MEDICAL PRODUCTS, LLC
- 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 54701 WAS CONDUCTED, NO MALFUNCTIONS WERE FOUND. THIS IS THE ONLY COMPLAINT FOR LOT 54701. FURTHER INVESTIGATION WILL BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF COMPLAINT.
NO DEVICE WAS RETURNED FOR TESTING. RETAINED LOT NUMBER 54701 WAS INVESTIGATED FOR ABNORMALITIES AND NO MALFUNCTION WAS FOUND. FOR FURTHER ANALYSIS ON THE COMPLAINT, OTHER BRANDS WILL BE PURCHASED OF SIMILAR SYRINGES AND THE NEEDLE CAP REMOVAL PROCESS WILL BE PERFORMED TO DETERMINE IF THERE IS ROOM FOR IMPROVEMENT IN THE NEEDLE CAP AND SYRINGE BARREL DESIGN.
NO DEVICE WAS RETURNED FOR TESTING. RETAINED LOT NUMBER 54701 WAS INVESTIGATED FOR ABNORMALITIES AND NO MALFUNCTION WAS FOUND. FOR FURTHER ANALYSIS ON THE COMPLAINT, OTHER BRANDS WILL BE PURCHASED OF SIMILAR SYRINGES AND THE NEEDLE CAP REMOVAL PROCESS WILL BE PERFORMED TO DETERMINE IF THERE IS ROOM FOR IMPROVEMENT IN THE NEEDLE CAP AND SYRINGE BARREL DESIGN. AFTER INVESTIGATING 50 COUNT OF THE INSULIN SYRINGES IN COMPARISON TO ANOTHER COMPARABLE BRAND, BY USING BOTH TOOLS AND THEIR HANDS THE CONCLUSION WAS THAT USING A TOOL TO REMOVE THE CAP OF THE INSULIN SYRINGE RESULTED IN CAUSING LESS DAMAGE TO THE NEEDLE TIP. HOWEVER, WHEN REMOVING THE REMOVING THE CAP WITH ONE'S HAND THAT A NEEDLE BURR MAY OCCUR DESPITE THE PRODUCT.
END USER REPORTS THAT INSULIN SYRINGES FROM LOT# 54701 EXPIRATION DATE 08/19/2026 ARE CAUSING PAIN DUE TO THE REPORTED CANNULA TIP BEING SPLIT.
END USER REPORTS THAT INSULIN SYRINGES FROM LOT# 54701 EXPIRATION DATE 08/19/2026 ARE CAUSING PAIN DUE TO THE REPORTED CANNULA TIP BEING SPLIT.
END USER REPORTS THAT INSULIN SYRINGES FROM LOT# 54701 EXPIRATION DATE 08/19/2026 ARE CAUSING PAIN DUE TO THE REPORTED CANNULA TIP BEING SPLIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 197434 | EASY TOUCH | SYRINGE | FMF | MHC MEDICAL PRODUCTS, LLC | 54701 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |