BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-T-PRO

    MDR report key: 4342813 · Received December 18, 2014

    Report

    Report Number
    1823260-2014-10146
    Event Type
    Malfunction
    Date Received
    December 18, 2014
    Date of Event
    September 1, 2014
    Report Date
    December 18, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    REPORTER STATED THE LANCET FROM A SAFE-T-PRO DEVICE DID NOT RETRACT AFTER USE. A NURSE PICKED UP THE DEVICE AND HAD AN ACCIDENTAL NEEDLE- STICK ON THEIR THUMB. THE NURSE RECEIVED STANDARD TREATMENT FOR EXPOSURE, WHICH INCLUDED AN EVALUATION, BLOOD DRAW, AND FOLLOW-UP VISITS. THE NURSE DID NOT CONTRACT A DISEASE AS A RESULT OF THE NEEDLE- STICK. NO PRODUCT IS AVAILABLE TO RETURN FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832784 SAFE-T-PRO LANCET FMK ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1