BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE TECA CONCENTRIC NEEDLE

    MDR report key: 5367593 · Received January 14, 2016

    Report

    Report Number
    3005581270-2016-00001
    Event Type
    Malfunction
    Date Received
    January 14, 2016
    Date of Event
    December 17, 2015
    Report Date
    December 17, 2015
    Manufacturer
    NATUS MANUFACTURING LIMITED
    Product Code
    GXZ
    PMA / PMN Number
    K112034
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS BEEN CONTACTED TO PROVIDE THE REST OF THE REQUIRED INFORMATION. WE ARE IN THE PROCESS OF GATHERING ADDITIONAL INFORMATION. A LETTER LISTING OUTSTANDING INFORMATION HAS BEEN SENT TO CUSTOMER TO OBTAIN ADDITIONAL INFORMATION IN ORDER TO SUBMIT FOLLOW UP REPORT AND/OR EXPLAIN WHY REQUIRED INFORMATION WAS NOT PROVIDED AND STEPS TAKEN TO OBTAIN SUCH INFORMATION. DEVICE NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE RETAINS LOG FOR THIS SN STATED THAT THIS LOT OF NEEDLES HAD BEEN TAKEN FOR TESTING FOR A SEPARATE COMPLAINT, CC001300. THIS COMPLAINT STATES THAT THERE WERE BURRS IN THE NEEDLES. ALL 25 RETAIN NEEDLES WERE TESTED AND NO ISSUES WERE NOTED. THIS WORK ORDER HAS BEEN REVIEWED AND THE SEAL STRENGTH TEST RESULTS HAVE BEEN INVESTIGATED. THE SPECIFICATION FOR A PASS IN SEAL STRENGTH IS 1.2N, THE RESULTS RANGED FROM 2.508N - 3.446N FOR THIS LOT WHICH IS ABOVE SPECIFICATION. STOCK WAS CHECKED ON ORACLE FOR THIS LOT NUMBER. NO LOTS ARE IN STOCK. CALIBRATION OF MULTITEST1-D, UNIT TO TEST SEAL STRENGTH FOR NEEDLE PACKAGING, WAS FOUND TO BE UP TO DATE. REACHED OUT THREE TIMES (18 DEC, 21 DEC AND 04 JAN) TO SALES REP TO GET MORE INFORMATION FROM THE COMPLAINANT ABOUT THE COMPLAINT. SALES REP HAS CONTACTED COMPLAINANT BUT HASN'T HAD ANY RESPONSE AS OF JAN 08TH.

    Description of Event or Problem · 1

    WHEN DOCTOR WENT OT USE NEEDLE, THE NEEDLE POUCH WAS NOT SEALED, OPEN POUCH IN BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25147 DISPOSABLE TECA CONCENTRIC NEEDLE ELECTRODE GXZ NATUS MANUFACTURING LIMITED S53156 13C/15/TG

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other