BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ PROTECTOR P55

    MDR report key: 8799552 · Received July 17, 2019

    Report

    Report Number
    3003152976-2019-00471
    Event Type
    Malfunction
    Date Received
    July 17, 2019
    Date of Event
    July 1, 2019
    Report Date
    August 13, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    30382905151171
    PMA / PMN Number
    K130197
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE SAMPLE WAS RETURNED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A FOREIGN PARTICLE WAS FOUND INSIDE THE VIAL. THERE WE NO DEFECTS OR DAMAGE OBSERVED, THE PROTECTOR FIT SECURELY TO THE VIAL, AND THE NEEDLE ON THE PROTECTOR PENETRATED THE VIAL STOPPER PROPERLY. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1901122, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. THE MATTER WAS IDENTIFIED TO BE A PARTICLE FROM THE RUBBER STOPPER. FRAGMENTATION TESTING IS PERFORMED ACCORDING TO PROCEDURE, TO EVALUATE ANY PARTICULATES GENERATED BY THE INJECTOR WHEN MATED TO OTHER COMPONENTS AFTER TEN ACTIVATIONS. FRAGMENTATION TESTING WAS REVIEWED FOR THE REPORTED LOT AND RESULTS WERE FOUND TO BE ACCEPTABLE. FIVE RETAINED SAMPLES OF THE SAME LOT WERE USED TO CONDUCT ADDITIONAL FRAGMENTATION TESTING. AFTER CONNECTING THE PROTECTOR USING THE M12ASSEMBLY FIXTURE PER THE INSTRUCTIONS FOR USE, NO FOREIGN MATTER WAS IDENTIFIED. 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 WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PHASEAL¿ PROTECTOR P55 HAD CORING. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN PREPARING RAMUCIRMAB, CORING OCCURRED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PHASEAL¿ PROTECTOR P55 HAD CORING. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN PREPARING RAMUCIRMAB, CORING OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592740 BD PHASEAL¿ PROTECTOR P55 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 1901122 30382905151171

    Patients

    Seq Age Sex Outcome Treatment
    1 Other