BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP SYRINGE

    MDR report key: 15626659 · Received October 18, 2022

    Report

    Report Number
    1911916-2022-00567
    Event Type
    Malfunction
    Date Received
    October 18, 2022
    Date of Event
    September 21, 2022
    Report Date
    September 23, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903028307
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. IT WAS REPORTED SYRINGES WERE EITHER MISSING THE HUB SCALE MARKINGS PARTIALLY OR ENTIRELY. TO AID IN THE INVESTIGATION, SIX SAMPLES IN SEALED PACKAGING BLISTERS AND THREE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND THE SYRINGES HAVE SCALE MARKING ISSUES. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302830, LOT NUMBER 2152001. THE REVIEW REVEALED THERE WAS AN INCIDENT REPORTED DURING THE PRODUCTION OF THIS BATCH. IT COULD BE POSSIBLE THE PRODUCTS RECEIVED WERE ESCAPES FROM THIS INCIDENT. THE PRODUCTS IDENTIFIED AS AFFECTED WERE SEGREGATED AND SCRAPPED. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION 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 AN UNSPECIFIED NUMBER OF BD LUER-LOK¿ TIP SYRINGES EXPERIENCED MISSING SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE SEVERAL BD 20 ML SYRINGES EITHER MISSING THE HUB DEMARCATIONS ENTIRELY OR PARTIALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340719 BD LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 302830 2152001 30382903028307

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown