BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXINEEDLES

    MDR report key: 239699 · Received September 30, 1999

    Report

    Report Number
    239699
    Event Type
    Malfunction
    Date Received
    September 30, 1999
    Date of Event
    August 19, 1999
    Report Date
    August 23, 1999
    Manufacturer
    BEST MEDICAL INDUSTRIES
    Product Code
    IWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INTERSTITIAL IMPLANT WITH 9YN 3 TEMPLATE. OF THE 39 15 GAUGE DISPOSABLE INTERSTITIAL NEEDLES WITH LUERLOCK STYLETS SENT TO OR, AT THE COMPLETION OF THE PROCEDURE 10 NEEDLES HAD BROKEN TIPS AND 2 NEEDLES HAD FRACTURED STYLETS. 25 NEEDLES HAD BEEN IMPLANTED OF THOSE A SIGNIFICANT NUMBER HAD BEEN COMPROMISED AND ONE WAS FOUND TO BE BROKEN. 25 NEEDLES WERE REMOVED FROM THE PT 16 SHOWED DAMAGE. NEEDLE #10 WAS ISOLATED REVEALING A 3.5 CM SEGMENT OF CATHETER/STYLET REMAINING IN THE PT, THE BROKEN SEGMENT WAS DETACHED AND DISPLAYED FROM THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXINEEDLES Implant DISPOSIBLE INTERSTITIAL NEEDLE WITH LUER LOCK STYLETS IWJ BEST MEDICAL INDUSTRIES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other