BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ INJECTOR LUER LOCK N35

    MDR report key: 7627598 · Received June 21, 2018

    Report

    Report Number
    3003152976-2018-00253
    Event Type
    Malfunction
    Date Received
    June 21, 2018
    Date of Event
    June 5, 2018
    Report Date
    July 18, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    30382905150037
    PMA / PMN Number
    K140591
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    THREE PICTURE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER. NO PHYSICAL SAMPLES ARRIVED AT (B)(6). UPON VISUAL INSPECTION OF THE PICTURE SAMPLES, FOREIGN MATTER WAS OBSERVED ON THE SURFACE OF THE INJECTOR. THERE ARE TWO POTENTIAL CAUSES FOR THE FOREIGN MATTER OBSERVED. THE FOREIGN MATTER APPEARED TO BE PLASTIC FROM THE CYLINDER WITHIN THE MANUFACTURING FACILITY OR TALC, WHICH IS USED DURING THE ASSEMBLY PROCESS. IF THE PARTICLES CAME FROM THE CYLINDER, ANY BRUSH BETWEEN THE COMPONENTS AND THE MACHINERY MAY HAVE RESULTED IN THE INTRODUCTION OF FOREIGN MATTER. TALC, A MATERIAL COMPLIANT WITH EUROPEAN PHARMACOPEIA REQUIREMENTS, IS USED WITHIN THE ASSEMBLY PROCESS TO MOVE THE LINE FORWARD. IT IS POSSIBLE THE FOREIGN MATTER IS RESIDUAL TALC. PHASEAL PRODUCTS ARE MANUFACTURED ACCORDING TO ISO 13485 REQUIREMENTS IN A CLASS 8 CLEAN AREA ACCORDING TO ISO 14644-1. DEVICE HISTORY RECORD REVIEW SHOWS THAT DURING THE PRODUCTION OF LOT NUMBER 1801111, NO QUALITY NOTIFICATIONS OR MAINTENANCE INTERVENTIONS WERE INITIATED IN RELATION TO EITHER POTENTIAL CAUSE. A NEW PROJECT HAS BEEN OPENED TO IMPROVE THE CLEANING PROCESS OF THE MANUFACTURING LINES. THE LOT REPORTED IN THIS INCIDENT WAS MANUFACTURED BEFORE THE IMPLEMENTATION OF THESE IMPROVEMENTS. BASED ON THE LOW SEVERITY AND FREQUENCY OF THE DEFECT, IT WAS DETERMINED THAT NO CAPA IS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WITH USE A BD PHASEAL¿ INJECTOR LUER LOCK N35 WAS FOUND WITH FOREIGN MATTER AS ¿BLUE PARTICLES ON WHITE PART OF THE INJECTOR BY TAKING OUT OF EMBALLAGE."THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    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 WITH USE A BD PHASEAL¿ INJECTOR LUER LOCK N35 WAS FOUND WITH FOREIGN MATTER AS ¿BLUE PARTICLES ON WHITE PART OF THE INJECTOR BY TAKING OUT OF EMBALLAGE."THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468725 BD PHASEAL¿ INJECTOR LUER LOCK N35 INJECTOR ONB BECTON DICKINSON, S.A. 1801111 30382905150037

    Patients

    Seq Age Sex Outcome Treatment
    1 Other