BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTOUCH

    MDR report key: 21610240 · Received March 14, 2025

    Report

    Report Number
    3005798905-2025-03246
    Event Type
    Malfunction
    Date Received
    March 14, 2025
    Date of Event
    February 25, 2025
    Report Date
    March 13, 2025
    Manufacturer
    BERPU MEDICAL TECHNOLOGY 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 70814 WAS CONDUCTED, NO MALFUNCTIONS WERE FOUND. THIS IS THE ONLY COMPLAINT FOR LOT 70814. FURTHER INVESTIGATION WILL BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF COMPLAINT.

    Additional Manufacturer Narrative · 0

    ANALYSIS SHOWS THAT THE PRODUCT MAY HAVE BEEN DAMAGED DURING LOGISTICS UNLOADING OR SUBSEQUENT TRANSPORTATION, NOT DUE TO THE QUALITY OF THE PRODUCT ITSELF.

    Description of Event or Problem · 0

    MHC DIRECT CUSTOMER - BPL SOURCE - REPORTED THAT UPON DELIVERY OF PO 103037 THAT 3 CASES WERE DAMAGED. A WAREHOUSE WORKER AT BPL SOURCE WAS STUCK WITH AN UNCAPPED NEEDLE FROM A DAMAGED CASE OF ITEM 830165 LOT 70814 WHILE HANDLING THE DAMAGED CASES OF PRODUCT.

    Description of Event or Problem · 0

    MHC DIRECT CUSTOMER - BPL SOURCE - REPORTED THAT UPON DELIVERY OF PO (B)(4) THAT 3 CASES WERE DAMAGED. A WAREHOUSE WORKER AT BPL SOURCE WAS STUCK WITH AN UNCAPPED NEEDLE FROM A DAMAGED CASE OF ITEM 830165 LOT 70814 WHILE HANDLING THE DAMAGED CASES OF PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561720 EASYTOUCH SYRINGE FMF BERPU MEDICAL TECHNOLOGY CO., LTD 70814

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown