BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFE-T-PRO

    MDR report key: 4813410 · Received June 2, 2015

    Report

    Report Number
    3011393376-2015-00806
    Event Type
    Injury
    Date Received
    June 2, 2015
    Date of Event
    February 28, 2015
    Report Date
    July 21, 2015
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    REPORTER STATED 2 SAFE-T-PRO LANCETS DID NOT RETRACT AFTER FIRING. BOTH EVENTS OCCURRED WITH THE SAME NURSE. ON (B)(6) 2015, THE NURSE WAS ACCIDENTALLY STUCK WITH THE NON-RETRACTED LANCET AFTER USING THE DEVICE ON A PATIENT. SHE HAD LAB WORK DONE AND WAS GIVEN A (B)(6) VACCINE. NO FURTHER TREATMENT INFORMATION WAS AVAILABLE. ON (B)(6) 2015, THE LANCET DID NOT RETRACT BUT NO ACCIDENTAL NEEDLESTICK OCCURRED. THE ALLEGED PRODUCT WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354008 SAFE-T-PRO LANCET FMK ROCHE DIABETES CARE, INC. NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention