BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 20ML LUER-LOK¿ SYRINGE

    MDR report key: 17086158 · Received June 8, 2023

    Report

    Report Number
    9614033-2023-00045
    Event Type
    Malfunction
    Date Received
    June 8, 2023
    Date of Event
    May 1, 2023
    Report Date
    June 6, 2023
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE PHOTO RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL EVALUATION, A PLASTIC BAG WITH SYRINGES INSIDE IS OBSERVED. UNABLE TO CONFIRM FAILURE BASED ON THE IMAGE DISPLAYED. PHYSICAL SAMPLES ARE REQUIRED TO FURTHER ANALYZE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2161837, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. 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 · 0

    IT WAS REPORTED THAT DURING USE WITH BD 20ML LUER-LOK¿ SYRINGE THE PLUNGER WAS DIFFICULT TO MOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THE BARREL IS THINNER WHERE THE PLUNGER GETS STUCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276377 BD 20ML LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 2161837

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown