BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NOKOR¿ FILTER NEEDLE

    MDR report key: 7752025 · Received August 6, 2018

    Report

    Report Number
    1911916-2018-00427
    Event Type
    Malfunction
    Date Received
    August 6, 2018
    Date of Event
    July 16, 2018
    Report Date
    September 14, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    30382903052005
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: NO. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED. BATCH 7020612 WAS PACKAGED ON MULTIVAC LINE 4 FOR A QUANTITY OF 360,000 ON ONE SHIFT 1/23/2017. THE CLEANING WAS PERFORMED AS REQUIRED. ASSEMBLY BATCH 6300802 FED INTO PACKAGE BATCH 7020612. ASSEMBLY BATCH 6300802 WAS PRODUCED ON NIP LINE 7 FOR A QUANTITY OF (B)(4) ON 1/18/2017 ¿ 1/20/2017. THERE WERE 50 VISUAL INSPECTIONS PERFORMED ON 2,500 PARTS WITH ZERO DEFECTS NOTED. SHIFT CLEANING WAS PERFORMED 7 TIMES THROUGHOUT THE PRODUCTION RUN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD NOKOR¿ FILTER NEEDLE, A FOREIGN PARTICLE WAS NOTICED IN THE SYRINGE AFTER DOSE PREPARATION. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN USING THE BD NOKOR¿ FILTER NEEDLE, A FOREIGN PARTICLE WAS NOTICED IN THE SYRINGE AFTER DOSE PREPARATION. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596316 BD NOKOR¿ FILTER NEEDLE FILTER NEEDLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 7020612 30382903052005

    Patients

    Seq Age Sex Outcome Treatment
    1 Other