BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 16GX1-1/2IN RB

    MDR report key: 9403515 · Received December 3, 2019

    Report

    Report Number
    1911916-2019-01266
    Event Type
    Malfunction
    Date Received
    December 3, 2019
    Date of Event
    November 12, 2019
    Report Date
    December 9, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051985
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THREE SAMPLES WERE RECEIVED. ONE PHOTO WAS PROVIDED. ONE SAMPLE CAME WITH NO PACKAGING BLISTER. IT HAS THE PLASTIC SHIELD AND HAS WHITE EPOXY TOWARDS THE TIP OF THE NEEDLE. THIS IS THE SAME AS THE ONE SHOWN ON THE PHOTO. THE OTHER TWO SAMPLES CAME IN THE SEALED PACKAGING BLISTER. VISUAL INSPECTION WAS PERFORMED. THEY DO NOT HAVE EPOXY ON THE NEEDLE OR ANY OTHER DEFECT. 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. IN THIS CASE IT MAY HAVE HAPPENED THAT A JAM OCCURRED AND THE EQUIPMENT DISPENSED SILICONE BEFORE THE PART WAS MOVED TO THE NEXT STATION AND IT WAS NOT DETECTED IN THE NEXT PROCESSES. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT EXCESS EPOXY WAS FOUND ON THE NEEDLE 16GX1-1/2IN RB BODY BEFORE USE. THIS OCCURRED ON 3 SEPARATE OCCASIONS, BUT THE DATES ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF OUR PHARMACY TECHS FOUND THESE WHILE PREPARING SOME MEDICATION. I HAVE 3 NEEDLES FROM LOT 9030971 THAT HAVE THIS WHITE MATERIAL ON THE NEEDLE BODY.

    Additional Manufacturer Narrative · 1

    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 EXCESS EPOXY WAS FOUND ON THE NEEDLE 16GX1-1/2IN RB BODY BEFORE USE. THIS OCCURRED ON 3 SEPARATE OCCASIONS, BUT THE DATES ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF OUR PHARMACY TECHS FOUND THESE WHILE PREPARING SOME MEDICATION. I HAVE 3 NEEDLES FROM LOT 9030971 THAT HAVE THIS WHITE MATERIAL ON THE NEEDLE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201696 NEEDLE 16GX1-1/2IN RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305198 9030971 30382903051985

    Patients

    Seq Age Sex Outcome Treatment
    1 Other