BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE TECA CONCENTRIC NEEDLE

    MDR report key: 5107353 · Received September 28, 2015

    Report

    Report Number
    3005581270-2015-00004
    Event Type
    Injury
    Date Received
    September 28, 2015
    Date of Event
    July 16, 2015
    Report Date
    July 28, 2015
    Manufacturer
    NATUS MANUFACTURING LIMITED
    Product Code
    GXZ
    PMA / PMN Number
    K112034
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REGISTERED INTERNALLY AS A COMPLAINT ((B)(4)) FOR INVESTIGATION PURPOSES. NEEDLE IN ROUTE TO NATUS FOR INVESTIGATION. FOR THIS EVENT, THE DOCTOR NOTICED THE NEEDLE SEPARATION AND DID NOT PRICK HERSELF. THE DEVICE HISTORY RECORD FOR (B)(4) LOT 08A/15/TG WAS OBTAINED AND REVIEWED. IN PROCESS TESTING AND INSPECTIONS WERE REVIEWED. ALL SAMPLES TAKEN FOR TESTS GAVE ACCEPTABLE RESULT. NO ISSUES WERE NOTED. ALL CHECKS WERE COMPLETED AS REQUIRED BY THE PROCESS AND QUALITY PLAN FOR THE CONCENTRIC NEEDLE. NO EXCESSIVE SCRAP QUANTITIES WERE NOTED. NO REWORK OR SORT PERFORMED ON THIS LOT. NO NCR'S NOTED FOR THIS LOT. THE CUSTOMER COMPLAINTS LOG WAS REVIEWED FOR THE LAST 12 MONTHS AND NO OTHER COMPLAINT FOR THIS ISSUE HAVE ARISEN. RETAINS FROM THIS BATCH WERE REQUESTED AND RECEIVED.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING HAS BEEN CORRECTED: DATE OF THIS REPORT - CORRECTED TO 07/28/2015 (WHEN REPORTED TO COMPANY) FROM 08/31/2015 DEVICE EVALUATED BY MANUFACTURER? - CORRECTED FROM ''NO: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN'' TO ''DEVICE NOT RETURNED FOR EVALUATION''.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT AFTER THE FIRST NEEDLE INSERTION, THE USER PUTS THE "USED" NEEDLE BACK INTO THE NEEDLE SHEATH WHICH IS HELD BY AN EMG NEEDLE HOLDER NEAR THE MACHINE. WHEN THEY TAKE THE NEEDLE BACK OUT OF THE SHEATH TO USE AGAIN ON THE PATIENT, THE NEEDLE IS DETACHING FROM THE RED HUB. GURVARINDER SAYS THEY HAVE USED OUR NEEDLES FOR A VERY LONG TIME. THEY HAVE THREE BAD NEEDLES FROM THE SAME BOX THAT THIS HAS OCCURRED. SHE FEELS THIS IS A SAFETY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638959 DISPOSABLE TECA CONCENTRIC NEEDLE ELECTRODE GXZ NATUS MANUFACTURING LIMITED S53153 08A/15/TG

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other