BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE STERILE

    MDR report key: 15460389 · Received September 21, 2022

    Report

    Report Number
    1911916-2022-00512
    Event Type
    Malfunction
    Date Received
    September 21, 2022
    Date of Event
    August 26, 2022
    Report Date
    September 8, 2022
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED SOME OF THE SYRINGES WERE MISSING THE SCALE MARKING. TO AID IN THE INVESTIGATION, ONE PHOTO AND ONE SAMPLE WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A SYRINGE WITH NO SCALE MARKING. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE SAMPLE RECEIVED IS THE ONE VISUALIZED IN THE PHOTO. THIS DEFECT COULD OCCUR IF THERE WAS A JAM DURING THE BARREL PRINTING PROCESS INDUCING THE SYMPTOM REPORTED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER: 309653, LOT NUMBER: 2090588. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. VERIFICATION OF THE SYRINGE BARREL PRINTING PROCESS WAS PERFORMED. THE SETTINGS WERE CORRECT AND THE FLOW OF PRODUCT WAS GOOD. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE 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 3 BD LUER-LOK¿ SYRINGE STERILE HAD OPAQUE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THREE BD 50ML SYRINGES LUER-LOK TIP (REF: (B)(4) UPON OPENING FROM INTACT PACKAGING ALL HAD OPAQUE MARKINGS ON THE SYRINGE BARRELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2791897 BD LUER-LOK¿ SYRINGE STERILE PISTON SYRINGE FMF BECTON DICKINSON AND COMPANY 309653 2179954 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown