BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASY TOUCH

    MDR report key: 14428997 · Received May 18, 2022

    Report

    Report Number
    3005798905-2022-03059
    Event Type
    Malfunction
    Date Received
    May 18, 2022
    Date of Event
    May 9, 2022
    Report Date
    May 17, 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

    Additional Manufacturer Narrative · 0

    INITIAL TREND ANALYSIS FOR LOT 54533 WAS CONDUCTED, NO MALFUNCTIONS WERE FOUND. THIS IS THE ONLY COMPLAINT FOR LOT 54533. FURTHER INVESTIGATION WILL BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF COMPLAINT.

    Additional Manufacturer Narrative · 0

    ON 8-10-2022, AN UPDATED PHOTO OF THE TWO SENSORS ON BOTH THE LEFT AND THE RIGHT OF THE CAPPING STATION THAT WERE ADDED TO DETECT THE ACCURACY OF THE INSPECTION WAS SENT TO SHOW PROGRESS IN THE MANUFACTURING PROCESS. AS WELL AS THE EFFECTIVENESS TRACKING INVESTIGATION FOLLOW-UP SHEET THAT TRACKED 5 BATCHES OF SYRINGE PRODUCTION ON THE ASSEMBLY LINE. NO DEFECTIVE PRODUCT OCCURED.

    Description of Event or Problem · 0

    END USER REPORTED THAT THE INSULIN SYRINGES BEING USED WITH TESTOSTERONE INJECTIONS FROM LOT NUMBER 54533 EXPIRATION DATE 06/19/2026 ITEM NUMBER 829155, WERE FOUND WITH 10 IN THE BOX WITH THE "NEEDLE BENT, THE BARREL WAS CRACKED AND THE BARREL WAS ALSO WARPED SUCH AS THE SYRINGE HAS BEEN EXPOSED TO SEVERE HEAT." THE INSULIN SYRINGE BOX THE 10 DAMAGED NEEDLES WERE FOUND DOES NOT APPEAR TO BE DAMAGED IN ANY WAY. IN FURTHER COMMUNICATION WITH THE SAME END USER FROM COMPLAINT ID# (B)(4) FOLLOW-UP CALL MADE ON 05-12-2022, THE END USER MADE CONCERN AT THE STERILIZATION OF THE INSULIN SYRINGES DUE TO THE USAGE OF SOME SYRINGES IN THE BOX PRIOR TO DETECTING THE WARPED AND BENT SYRINGES.

    Description of Event or Problem · 0

    END USER REPORTED THAT THE INSULIN SYRINGES BEING USED WITH TESTOTERONE INJECTIONS FROM LOT NUMBER 54533 EXPIRATION DATE 06/19/2026 ITEM NUMBER 829155, WERE FOUND WITH 10 IN THE BOX WITH THE "NEEDLE BENT, THE BARREL WAS CRACKED AND THE BARREL WAS ALSO WARPED SUCH AS THE SYRINGE HAS BEEN EXPOSED TO SEVERE HEAT." THE INSULIN SYRINGE BOX THE 10 DAMAGED NEEDLES WERE FOUND DOES NOT APPEAR TO BE DAMAGED IN ANY WAY. IN FURTHER COMMUNICATION WITH THE SAME END USER FROM COMPLAINT ID# (B)(4) FOLLOW-UP CALL MADE ON 05-12-2022, THE END USER MADE CONCERN AT THE STERILIZATION OF THE INSULIN SYRINGES DUE TO THE USAGE OF SOME SYRINGES IN THE BOX PRIOR TO DETECTING THE WARPED AND BENT SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2762829 EASY TOUCH INSULIN SYRINGES FMF MHC MEDICAL PRODUCTS, LLC 54533

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown