BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL INJECTOR LUER LOCK (N35C)

    MDR report key: 12638877 · Received October 15, 2021

    Report

    Report Number
    3003152976-2021-00688
    Event Type
    Malfunction
    Date Received
    October 15, 2021
    Date of Event
    September 17, 2021
    Report Date
    September 27, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    50382905150055
    PMA / PMN Number
    K140591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO PHOTO OR SAMPLE RECEIVED FOR INVESTIGATION. FIVE RETAINED SAMPLES FROM THE SAME LOT WERE EVALUATED, UPON VISUAL INSPECTION, NO DEFECTS OR DAMAGE TO THE INJECTOR MEMBRANES WERE OBSERVED. FRAGMENTATION TESTING IS PERFORMED ACCORDING TO PROCEDURE, TO EVALUATE ANY PARTICULATES GENERATED BY THE INJECTOR WHEN MATED TO OTHER COMPONENTS AFTER TEN ACTIVATIONS. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2010013, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED ISSUE. WHILE PHASEAL NEEDLES ARE DESIGNED TO REDUCE CORING, THERE ARE SEVERAL FACTORS THAT MAY IMPACT CORING TENDENCY. CORING FROM THE MEMBRANE MAY OCCUR DUE TO FRAGMENTATION CAUSED BY MULTIPLE INJECTIONS OR EXCESSIVE WELDING OF THE MEMBRANE. CORING OF THE RUBBER STOPPER MAY RESULT DEPENDING ON THE STOPPER QUALITY, THE DESIGN AND DIMENSIONS OF THE NEEDLES USED, OR IF A POOR CONNECTION OF THE PROTECTOR OCCURS. IT IS IMPORTANT TO ENSURE THE VIAL IS NOT EXPIRED AS THAT CAN IMPACT THE QUALITY OF THE RUBBER STOPPER. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED FOR FUTURE OCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHITE PARTICLES WERE FOUND IN THE ETOPOSID VIAL AFTER THE BD PHASEAL¿ INJECTOR LUER LOCK (N35C) WAS USED WITH IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHARMACY HAVE PREPARED WITH PHASEAL FOR SEVERAL YEARS ALL CYTOS. NOW THEY REALIZED WHITE PARTICLES IN DRUG AFTER USED INJECTOR. DRUG IS ETOPOSID. THOSE PARTICLES MELT IN LIQUID. THEY DIDN'T USE THAT DRUG FOR PATIENT." "PARTICLES WERE SEEN JUST AFTER LIQUID PUSHED INTO VIAL. THEN PARTICLES MELT AWAY. THEY DECIDED NOT TO USE THAT DRUG AND THROWED AWAY THOSE PHASEAL PARTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1537298 BD PHASEAL INJECTOR LUER LOCK (N35C) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515005 2010013 50382905150055

    Patients

    Seq Age Sex Outcome Treatment
    1