BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD¿ SYRINGE WITH NEEDLE

    MDR report key: 13238027 · Received January 12, 2022

    Report

    Report Number
    3002682307-2021-00688
    Event Type
    Malfunction
    Date Received
    January 12, 2022
    Date of Event
    November 29, 2021
    Report Date
    December 29, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: AS NEITHER A LOT NUMBER NOR A SAMPLE WAS AVAILABLE FOR THIS INCIDENT, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. COMPLAINTS RECEIVED WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE OF THE BD EMERALD¿ SYRINGE WITH NEEDLE WAS BLOCKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "ON (B)(6)2021, WHEN THE NURSE WAS DOING AEROSOLIZED LIQUID MEDICINE FOR PATIENTS, THE LIQUID MEDICINE COULD NOT BE DRAWN OUT, AND THE NEEDLE WAS BLOCKED. REPLACE THE DEFECTIVE PRODUCT IN TIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941618 BD EMERALD¿ SYRINGE WITH NEEDLE PISTON SYRINGE FMF BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown