BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEIRIN ACUPUNCTURE NEEDLE WITH GUIDE TUBE

    MDR report key: 17451811 · Received August 2, 2023

    Report

    Report Number
    MW5120522
    Event Type
    Malfunction
    Date Received
    August 2, 2023
    Date of Event
    July 11, 2023
    Report Date
    July 31, 2023
    Manufacturer
    SEIRIN CORPORATION
    Product Code
    MQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ACUPUNCTURE NEEDLES- SEIRIN NO.4 (.23)X30MM J-TYPE NEEDLE HAS NO SAFETY SHIELD WITH THE J-TYPE. WHEN YOU OPEN NEEDLE IT CAN AND HAS FALLEN OUT OF BOTTOM. AT TIMES IT HAS GONE THROUGH PLASTIC WHERE THE NEEDLE WILL STICK YOUR HAND. THE PINK PART THAT IS SUPPOSED TO HOLD THE NEEDLE DOES NOT GRIP IT TIGHT, ALLOWING THE NEEDLE TO SLIDE DOWN OUT OF THE SHEATH AND HAS GONE THROUGH THE PACKAGING CAUSING A NEEDLE STICK TO STAFF WHO WAS ATTEMPTING TO OPEN AND PRESENT THE NEEDLE TO THE PROVIDER FOR USE. THIS WAS A CLEAN NEEDLE STICK BUT STILL CAUSED STAFF INJURY. THE L-TYPE HAS A SHEATH OF A DIFFERENT COLOR AND MATERIAL THAT HOLDS THE ACUPUNCTURE NEEDLE AND THESE NEEDLES DO NOT SLIDE DOWN AND POSE A RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773187 SEIRIN ACUPUNCTURE NEEDLE WITH GUIDE TUBE NEEDLE, ACUPUNCTURE, SINGLE USE MQX SEIRIN CORPORATION J-TYPE NO.4(0.23)X30MM 21721H1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other