BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0 ML 13X75 MM PLASTIC C&S PRESERVATIVE TUBE AND URINE TRANSFER STRAW.

    MDR report key: 7059646 · Received November 27, 2017

    Report

    Report Number
    1917413-2017-00149
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    May 18, 2016
    Report Date
    November 1, 2017
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JSM
    UDI-DI
    00382903649532
    PMA / PMN Number
    K024240
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A PHOTO WAS SENT THAT SHOWS A TRANSFER STRAW DETACHED FROM THE NEEDLE HOLDER. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5182966. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMERS¿ INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 4.0 ML 13X75 MM PLASTIC C&S PRESERVATIVE TUBE AND URINE TRANSFER STRAW HAD AN EXPOSED NEEDLE DUE TO THE HOLDER AND STRAW BEING SEPARATED. THE TECHNICIAN STUCK HER FINGER ON THE EXPOSED NEEDLE BEFORE USE. NO SERIOUS INJURY, NO MEDICAL INTERVENTIONS AND NO MUCOUS MEMBRANE EXPOSURE TO BODY FLUIDS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839013 4.0 ML 13X75 MM PLASTIC C&S PRESERVATIVE TUBE AND URINE TRANSFER STRAW. URINE TRANSFER KIT. JSM BECTON, DICKINSON & CO. 5182966 00382903649532

    Patients

    Seq Age Sex Outcome Treatment
    1 Other