BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK SYRINGE

    MDR report key: 9793504 · Received March 5, 2020

    Report

    Report Number
    3003152976-2020-00100
    Event Type
    Malfunction
    Date Received
    March 5, 2020
    Date of Event
    February 14, 2020
    Report Date
    April 15, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY ONE PHOTO AND ONE PHYSICAL SAMPLE WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR MOLDING DEFECTS WERE OBSERVED THAT COULD CONTRIBUTE TO THE REPORTED FAILURE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1911729, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THIS ISSUE WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. TEN RETAINED SAMPLES OF THE SAME LOT WERE USED FOR EVALUATION, NO DAMAGE OR MOLDING DEFECT OBSERVED. THROUGHOUT THE MANUFACTURING PROCESS, FORCE TESTING AND SILICONE CONTENT TESTS ARE CONDUCTED FOR EACH LOT. ALL RETAINED SAMPLES WERE EVALUATED AND FOUND TO BE WITHIN REQUIRED SPECIFICATIONS. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE PISTON WAS NOT "COMPLETELY FLAT" AND "DARKER IN THE MIDDLE", POSING A PROBLEM WHEN USING IT WITH THE SYRINGE PUMP DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "THE DIALYSIS COMMUNICATED TO US THAT SOME UNITS DO NOT HAVE THE PISTON COMPLETELY FLAT, IT IS DARKER IN THE MIDDLE, AND THAT POSES PROBLEM WHEN USING THE SYRINGE PUMP."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE PISTON WAS NOT "COMPLETELY FLAT" AND "DARKER IN THE MIDDLE", POSING A PROBLEM WHEN USING IT WITH THE SYRINGE PUMP DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE DIALYSIS COMMUNICATED TO US THAT SOME UNITS DO NOT HAVE THE PISTON COMPLETELY FLAT, IT IS DARKER IN THE MIDDLE, AND THAT POSES PROBLEM WHEN USING THE SYRINGE PUMP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259123 BD PLASTIPAK LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1911729

    Patients

    Seq Age Sex Outcome Treatment
    1 Other