BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK SYRINGE

    MDR report key: 8879212 · Received August 9, 2019

    Report

    Report Number
    3003152976-2019-00521
    Event Type
    Malfunction
    Date Received
    August 9, 2019
    Date of Event
    July 25, 2019
    Report Date
    September 12, 2019
    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
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE PHOTO AND ONE UNUSED SAMPLE WAS PROVIDED TO OUR QUALITY ENGINEER TEAM FOR INVESTIGATION. UPON VISUALLY INSPECTING THE PRODUCT , A BLACK PARTICLE WAS IDENTIFIED INSIDE THE SYRINGE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1905214, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THE REPORTED ISSUES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THROUGH OUR INVESTIGATION THE PARTICLE WAS IDENTIFIED TO BE A PIECE OF RESIDUAL TRIM FROM THE STOPPER. THIS COMPONENT IS PROVIDED BY AN EXTERNAL SUPPLIER. BASED ON THE AVAILABLE INFORMATION, A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS CANNOT BE IDENTIFIED AT THIS TIME. A SCAR, SUPPLIER CORRECTIVE ACTION REQUEST, HAS BEEN SENT TO THE SUPPLIER SITE REGARDING THIS ISSUE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED FOR FUTURE OCCURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A "LARGE PIECE OF RUBBER" WAS FOUND ATOP THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE PLUNGER BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: A LARGE PIECE OF RUBBER HAS BEEN FOUND ON TOP OF THE PLUNGER OF THE SYRINGE.

    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 A "LARGE PIECE OF RUBBER" WAS FOUND ATOP THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE PLUNGER BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: A LARGE PIECE OF RUBBER HAS BEEN FOUND ON TOP OF THE PLUNGER OF THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674219 BD PLASTIPAK LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1905214

    Patients

    Seq Age Sex Outcome Treatment
    1 Other