BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGUIDE NEEDLE SET

    MDR report key: 9123048 · Received September 26, 2019

    Report

    Report Number
    9611894-2019-00002
    Event Type
    Injury
    Date Received
    September 26, 2019
    Date of Event
    August 29, 2019
    Report Date
    February 28, 2020
    Manufacturer
    NUCLETRON B.V.
    Product Code
    JAQ
    UDI-DI
    08717213020450
    PMA / PMN Number
    K060349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    E2 UPDATED. E3 UPDATED. H6 UPDATED. H10 UPDATED: THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE REPORTED INFORMATION. IT WAS ASCERTAINED THAT DUE TO A HUMAN ERROR, AN INCORRECT ORDER WAS PLACED IN THE ORDERING SOFTWARE, AND ROUND PROGUIDE NEEDLES WERE DELIVERED INSTEAD OF THE SHARP NEEDLES AS REQUESTED BY THE CUSTOMER. THERE ARE NO INDICATIONS THAT THE PATIENT INJURY IS RELATED TO THE USE OF A MIX OF ROUND AND SHARP PROGUIDE NEEDLES DURING THE APPLICATION. THE ISSUE COULD NOT BE INVESTIGATED FURTHER BECAUSE NO DETAILED INFORMATION REGARDING THIS APPLICATION HAS BEEN RECEIVED FROM THE HOSPITAL, DESPITE A NUMBER OF REQUESTS.

    Additional Manufacturer Narrative · 1

    A PROSTATE BRACHYTHERAPY PROCEDURE WAS PERFORMED BY THE HOSPITAL. EIGHTEEN NEEDLES WERE PLACED IN THE PROSTATE AND THE PATIENT EXPERIENCED BLEEDING. THE HOSPITAL PERFORMED TWO SURGERIES TO CONTROL THE BLEEDING IN THE BLADDER AND GAVE A BLOOD TRANSFUSION. THE INVESTIGATION OF THIS CASE IS STILL ON-GOING BY ELEKTA WHOM ARE AWAITING FURTHER DETAILS FROM THE HOSPITAL. ELEKTA IS INVESTIGATING WHAT THE RELATIONSHIP IS BETWEEN THE BLEED AND THE USAGE OF THE PROGUIDE NEEDLES AND WHAT PROCEDURE DID THE HOSPITAL FOLLOW. THIS CASE IS THE FIRST CASE OF THIS KIND REPORTED TO ELEKTA.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEY ORDERED PROGUIDE SHARP NEEDLES FOR PROSTATE BRACHYTHERAPY BUT THEY INSTEAD RECEIVED PROGUIDE ROUND NEEDLES FOR PROSTATE BRACHYTHERAPY. THE PATIENT WAS BLEEDING DURING THE TREATMENT. THE CUSTOMER SUGGESTED A CONNECTION BETWEEN THE BLEEDING AND THE USAGE OF THE PROGUIDE NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915738 PROGUIDE NEEDLE SET SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED JAQ NUCLETRON B.V. 189623-01 60898539 08717213020450

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R