BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE VENTED NOKOR 18X1 TW

    MDR report key: 10131438 · Received June 8, 2020

    Report

    Report Number
    1911916-2020-00536
    Event Type
    Malfunction
    Date Received
    June 8, 2020
    Date of Event
    May 18, 2020
    Report Date
    May 22, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    30382903052142
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER STATE: ADDRESS INFORMATION WAS NOT ABLE TO BE OBTAINED. (B)(6) WAS USED AS A PLACE HOLDER BASED ON THE USER AREA CODE. (B)(4) INVESTIGATION SUMMARY: APPROXIMATELY 1000 SAMPLES WERE RECEIVED FOR EVALUATION (5 SHELF BOXES WITH 100 EACH AND ONE PLASTIC BACK WITH BULKED PACKAGING BLISTERS). ALL THE SAMPLES WERE IN SEALED PACKAGING BLISTERS. 200 SAMPLES WERE RANDOMLY SELECTED AND WERE VISUALLY INSPECTED WITH A 10X MAGNIFIER LENS. NO CORING WAS OBSERVED, NO OTHER DEFECT WAS OBSERVED. THE SYMPTOM REPORTED WAS NOT CONFIRMED. BATCH RECORDS SHOW NO ISSUES WERE EXPERIENCED WHILE PRODUCING THIS BATCH. SAMPLES RECEIVED WERE FOUND ACCEPTABLE. THEREFORE, NO FURTHER ACTION IS REQUIRED. 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: THIS IS THE 1ST COMPLAINT FOR LOT # 9162568 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. ROOT CAUSE DESCRIPTION: THE SYMPTOM REPORTED WAS NOT CONFIRMED. BATCH RECORDS SHOW NO ISSUES WERE EXPERIENCED WHILE PRODUCING THIS BATCH. SAMPLES RECEIVED WERE FOUND ACCEPTABLE. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLES ARE CORING PRIOR TO USE WITH A BD NEEDLE VENTED NOKOR 18X1 TW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED NEEDLES ARE CORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590866 BD NEEDLE VENTED NOKOR 18X1 TW MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 305214 9162568 30382903052142

    Patients

    Seq Age Sex Outcome Treatment
    1 Other