BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 60ML ST

    MDR report key: 12668815 · Received October 20, 2021

    Report

    Report Number
    1911916-2021-01090
    Event Type
    Malfunction
    Date Received
    October 20, 2021
    Date of Event
    September 22, 2021
    Report Date
    September 30, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: IT IS REPORTED THE PLUNGER IS DAMAGED. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS THE BOTTOM PART OF A SYRINGE WITH A ROLLED STOPPER. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THE RUBBER STOPPER WAS NOT PROPERLY ASSEMBLED TO THE PLUNGER ROD. WHEN THE PLUNGER ROD-RUBBER STOPPER WAS THEN ASSEMBLED TO THE SYRINGE BARREL, THE RUBBER STOPPER BECAME ROLLED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302829, LOT NUMBER 9182654. 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 RUBBER STOPPER ASSEMBLY PROCESS WAS PERFORMED. THE SETTINGS AND ALIGNMENT WAS CORRECT AND THE FLOW OF PRODUCTS WAS GOOD. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD SYRINGE 60ML ST, THE DEVICE EXPERIENCED A DEFECTIVE /DEFORMED STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE PLUNGER IS DAMAGED. IS THE PLUNGER BROKEN OR IS THE PLUNGER RUBBER (BLACK PART) DISPLACED? PLEASE CONFIRM DEVIATIONS. IT'S THE RUBBER (STOPPER) ON THE PLUNGER, IT SEEMS TO BE "MELTED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1561485 BD SYRINGE 60ML ST PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 9182654

    Patients

    Seq Age Sex Outcome Treatment
    1