BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NOKOR¿ FILTER NEEDLE

    MDR report key: 9678545 · Received February 6, 2020

    Report

    Report Number
    1911916-2020-00106
    Event Type
    Malfunction
    Date Received
    February 6, 2020
    Date of Event
    January 31, 2020
    Report Date
    February 3, 2020
    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 HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE. THIS IS THE 2ND COMPLAINT FOR LOT # 8052947 FOR THIS TYPE OF DEFECT OR SYMPTOM. PREVIOUS COMPLAINT (B)(4). THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECTS DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. ROOT CAUSE DESCRIPTION: NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD NOKOR¿ FILTER NEEDLE BROKE DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 5 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BROKEN FILTER NEEDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142909 BD NOKOR¿ FILTER NEEDLE MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 305200 8052947 30382903052005

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other