BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 25X5/8 RB NS

    MDR report key: 10075890 · Received May 20, 2020

    Report

    Report Number
    1911916-2020-00480
    Event Type
    Malfunction
    Date Received
    May 20, 2020
    Date of Event
    November 15, 2019
    Report Date
    May 18, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: ONE PHOTO WAS PROVIDED FOR EVALUATION. IT SHOWS THREE NEEDLE ASSEMBLIES WITH NO PLASTIC SHIELD. THE TWO SAMPLES HAVE WHITE EPOXY DRIP OVER THE PLASTIC HUB AND ONE HAS THE WHITE EPOXY OVER THE NEEDLE TOWARD THE NEEDLE TIP. THE PLASTIC HUB IS PLACED UNDER THE CANNULATOR THEN THE NEEDLE IS POSITIONED AND ASSEMBLED TO THE PLASTIC HUB ADDING THE WHITE EPOXY TO FIX IT; AFTER THAT, A PLASTIC HUB IS ASSEMBLED. IN THIS CASE, A JAM MAY HAVE OCCURRED AT THE CANNULATOR INDUCING THE EXCESS OF WHITE EPOXY ON THE NEEDLE AND THE PLASTIC HUB. 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 2ND COMPLAINT FOR LOT # 9052801 FOR THIS TYPE OF DEFECT OR SYMPTOM. PREVIOUS COMPLAINT (B)(4). THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. ROOT CAUSE DESCRIPTION: THE ROOT CAUSE WAS DUE TO NEEDLE ASSEMBLY LINE THE PLASTIC HUB IS PLACED UNDER THE CANNULATOR THEN THE NEEDLE IS POSITIONED AND ASSEMBLED TO THE PLASTIC HUB ADDING THE WHITE EPOXY TO FIX IT; AFTER THAT, A PLASTIC HUB IS ASSEMBLED. IN THIS CASE, A JAM MAY HAVE OCCURRED AT THE CANNULATOR INDUCING THE EXCESS OF WHITE EPOXY ON THE NEEDLE AND THE PLASTIC HUB. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 NEEDLE 25X5/8 RB NS EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 303010 BATCH NO: 9052801. CHALKY SUBSTANCE ON HUB OF NEEDLE, BEFORE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537260 NEEDLE 25X5/8 RB NS HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 9052801

    Patients

    Seq Age Sex Outcome Treatment
    1 Other