BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE 26X1/2 RB

    MDR report key: 9639152 · Received January 28, 2020

    Report

    Report Number
    1911916-2020-00063
    Event Type
    Malfunction
    Date Received
    January 28, 2020
    Date of Event
    December 21, 2019
    Report Date
    January 10, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051114
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION AS NO SAMPLE OR PHOTOS WERE PROVIDED. THEREFORE, BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AND A ROOT CAUSE CAN¿T BE CONFIRMED. A DHR WAS COMPLETED AND THIS IS THE 1ST COMPLAINT FOR LOT # 9029658 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECTS DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. 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.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ONE BD¿ NEEDLE 26X1/2 RB HAS BEEN FOUND DAMAGED AND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT INSULIN LEAKED OUT FROM NEEDLE FROM THE SYRINGE AS CUSTOMER WAS TRYING TO FILL INSULIN INTO CARTRIDGE AND THE SYRINGE/NEEDLE/CART LOOKED HEATED UP. DESCRIPTION OF ISSUE: CUSTOMER REPORTED INSULIN LEAKED OUT FROM NEEDLE FROM SYRINGE AS CUSTOMER WAS TRYING TO FILL INSULIN INTO CARTRIDGE. NUMBER OF OCCURRENCES: 1. ITEM NUMBER: BD 26 G, 3/8" NEEDLE ¿ 305111. PRODUCT LOT NUMBER: 9829658. CUSTOMER REPORTED REPLACED AND USED A NEW NEEDLE AND USED SAME SYRINGE TO FILL INSULIN INTO CARTRIDGE. CUSTOMER COMPLAINT UPON PACKAGING OF SYRINGE/NEEDLE/CART THAT LOOKS "HEATED UP". COMPLAINT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103457 BD NEEDLE 26X1/2 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305111 9029658 30382903051114

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other