BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAWKINS II FLEXSTRAND BLN 20GA X 10CM

    MDR report key: 13267124 · Received January 17, 2022

    Report

    Report Number
    0001625425-2022-00930
    Event Type
    Injury
    Date Received
    January 17, 2022
    Date of Event
    December 3, 2021
    Report Date
    March 9, 2022
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    GDM
    UDI-DI
    00886333003822
    PMA / PMN Number
    K870523
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE IS INDICATED AS AVAILABLE FOR RETURN. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN RETURNED. A FOLLOW-UP REPORT WILL BE PROVIDED ONCE THE DEVICE HAS BEEN RECEIVED AND REVIEWED.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DHR AND INSPECTION RECORDS WAS CONDUCTED, AND ALTHOUGH A TEMPORARY DEVIATION NOTICE WAS GIVEN, THERE IS NO EVIDENCE THAT IT CONTRIBUTES TO THE COMPLAINT. IT WAS NOT NECESSARY TO CHECK ANY OTHER DOCUMENTATION IN THE COURSE OF INVESTIGATING THIS COMPLAINT. A FUNCTIONAL ANALYSIS OF THE RETURNED SAMPLE WAS CONDUCTED, AND THE FOLLOWING FINDINGS ARE RELEVANT TO THE COMPLAINT: THE PRODUCT WAS NOT DAMAGED OR MISSING COMPONENTS. EXCESSIVE RESISTANCE WAS FELT. THE RETURNED GUIDEWIRE WAS USED TO PASS THROUGH THE NEEDLE OF THE SAMPLES. THERE WAS EXCESSIVE RESISTANCE FELT AS THE GUIDEWIRE MOVED THROUGH THE CANNULA. THIS IS OUTSIDE OF ARGON SPECIFICATION (NEEDLE MUST BE ABLE TO PASS THROUGH THE CANNULA). THEREFORE, THE COMPLAINT IS CONFIRMED. SINCE THE MANUFACTURE OF THIS LOT, TDN 120646 WAS ISSUED TO CORRECT THE STACK UP TOLERANCES ON OUR CURRENT DRAWINGS FOR THE TIME BEING. THE DRAWING USED (DWG-1280021-X) IS CURRENTLY BEING UPDATED WITH THE NEW TOLERANCES TO MAKE THESE CHANGES PERMANENT.

    Additional Manufacturer Narrative · 0

    THE SAMPLE IS INDICATED AS RETURNED. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN EVALUATED. A FOLLOW-UP REPORT WILL BE PROVIDED ONCE THE DEVICE HAS BEEN REVIEWED.

    Description of Event or Problem · 0

    WE HAVE SEVERAL OCCURRENCES WHEN USING THE 10CM NEEDLE WITH WIRE WHERE WE COULD NOT REMOVE THE NEEDLE OFF OF THE WIRE, IT GETS STUCK THE RADIOLOGIST HAD TO PULL WITH A LOT F FORCES TO REMOVE IT, IN A RECENT PROCEDURE IT GOT STUCK TO THE POINT THAT THEY COULD NOT REMOVE THE NEEDLE AND SENT THE PATIENT TO SURGERY WITH THE NEEDLE AND WIRE IN THE BREAST AS FAR AS I KNOW THIS HAS NOT HAPPENED WITH THE 5CM OR 12.5 NEEDLE WITH WIRE

    Description of Event or Problem · 0

    WE HAVE SEVERAL OCCURRENCES WHEN USING THE 10CM NEEDLE WITH WIRE WHERE WE COULD NOT REMOVE THE NEEDLE OFF OF THE WIRE, IT GETS STUCK THE RADIOLOGIST HAD TO PULL WITH A LOT F FORCES TO REMOVE IT, IN A RECENT PROCEDURE IT GOT STUCK TO THE POINT THAT THEY COULD NOT REMOVE THE NEEDLE AND SENT THE PATIENT TO SURGERY WITH THE NEEDLE AND WIRE IN THE BREAST AS FAR AS I KNOW THIS HAS NOT HAPPENED WITH THE 5CM OR 12.5 NEEDLE WITH WIRE.

    Description of Event or Problem · 0

    WE HAVE SEVERAL OCCURRENCES WHEN USING THE 10CM NEEDLE WITH WIRE WHERE WE COULD NOT REMOVE THE NEEDLE OFF OF THE WIRE, IT GETS STUCK THE RADIOLOGIST HAD TO PULL WITH A LOT F FORCES TO REMOVE IT, IN A RECENT PROCEDURE IT GOT STUCK TO THE POINT THAT THEY COULD NOT REMOVE THE NEEDLE AND SENT THE PATIENT TO SURGERY WITH THE NEEDLE AND WIRE IN THE BREAST AS FAR AS I KNOW THIS HAS NOT HAPPENED WITH THE 5CM OR 12.5 NEEDLE WITH WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808202 HAWKINS II FLEXSTRAND BLN 20GA X 10CM HAWKINS II FLEXSTRAND BLN GDM ARGON MEDICAL DEVICES 252100 11373483 00886333003822

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O