BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE, 50 ML

    MDR report key: 15375657 · Received September 7, 2022

    Report

    Report Number
    1911916-2022-00464
    Event Type
    Malfunction
    Date Received
    September 7, 2022
    Date of Event
    August 5, 2022
    Report Date
    August 16, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THERE WAS A CHUNK OF PLASTIC FLOATING AROUND IN FLUID ALONG WITH OTHER PARTICLES. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND THERE ARE PLASTIC PARTICLES AT THE BOTTOM OF A SYRINGE BARREL. THE SYRINGE BARREL INNER WALL HAS SCRATCHES AND THE RETAINING RING IS DAMAGED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR DURING THE MOLDING PROCESS WHEN THE MOLDING PART IS NOT EJECTED DURING THE FIRST ATTEMPT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT NUMBER 2153743. 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 MOLDING PROCESS WAS PERFORMED. THE SETTINGS WERE CORRECT AND THE EJECTIONS OF MOLDED PARTS WAS ACCEPTABLE. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. 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 PRIOR TO USING THE BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE, 50 ML, FOREIGN MATTER WAS OBSERVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE WAS A CHUNK OF PLASTIC FLOATING AROUND IN THE FLUID ALONG WITH OTHER PARTICLES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283709 BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE, 50 ML PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 2153743

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown