EASYTOUCH
Report
- Report Number
- 3005798905-2021-02997
- Event Type
- Malfunction
- Date Received
- April 9, 2021
- Date of Event
- March 8, 2021
- Report Date
- April 7, 2021
- 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
PRODUCTION RECORDS FOR LOTS 52215 AND 52211 WERE ANALYZED. NO ABNORMALITY WAS FOUND AT TIME OF PRODUCTION.
NO DEVICE WAS RETURNED FOR PRODUCT TESTING BUT PHOTOS OF THE PRODUCT WERE PROVIDED. PRODUCTION RECORDS FOR LOTS 52215 AND 52211 WERE ANALYZED. RETAINED LOT NUMBERS 52215 AND 52211 ANALYSIS SHOWED NO ABNORMALITY AT TIME OF PRODUCTION.
END USER REPORTS THAT SYRINGES ARE DULL AND BENT. HOWEVER, CUSTOMER SUGGESTS THAT THE PRODUCT IS NOT BEING USED FOR ITS INTENDED PURPOSE. SYRINGE LOT NUMBERS 52215 EXPIRATION DATE 07/20/2025 AND 52211 EXPIRATION DATE 07/16/2025.
END USER REPORTS THAT SYRINGES ARE DULL AND BENT. HOWEVER, CUSTOMER SUGGESTS THAT THE PRODUCT IS NOT BEING USED FOR ITS INTENDED PURPOSE. SYRINGE LOT NUMBERS 52215 EXPIRATION DATE 07/20/2025 AND 52211 EXPIRATION DATE 07/16/2025.
WHEN INITIAL TREND ANALYSIS FOR LOT NUMBERS 52215 AND 52211 WAS CONCLUDED THIS WAS THE ONLY COMPLAINT RECEIVED. FURTHER INVESTIGATION WILL BE CONDUCTED FOR ROOT CAUSE OF COMPLAINT.
END USER REPORTS THAT SYRINGES ARE DULL AND BENT. HOWEVER, CUSTOMER SUGGESTS THAT THE PRODUCT IS NOT BEING USED FOR ITS INTENDED PURPOSE. SYRINGE LOT NUMBERS 52215 EXPIRATION DATE 07/20/2025 AND 52211 EXPIRATION DATE 07/16/2025.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 539829 | EASYTOUCH | SYRINGE | FMF | MHC MEDICAL PRODUCTS, LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |