BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ LUER-LOK¿ SYRINGE

    MDR report key: 14407668 · Received May 16, 2022

    Report

    Report Number
    3003152976-2022-00214
    Event Type
    Malfunction
    Date Received
    May 16, 2022
    Date of Event
    April 25, 2022
    Report Date
    August 17, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES. D9: RETURNED TO MANUFACTURER ON: 11-JUL-2022 . H6: INVESTIGATION SUMMARY TWO SAMPLES AND TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A BLACK PARTICLE WAS OBSERVED INSIDE ONE SAMPLE. FURTHER EVALUATION IDENTIFIED THE PARTICLE TO BE A STOPPER FLAP THAT WAS DETACHED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2111002, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THIS COMPONENT IS PROVIDED BY AN EXTERNAL SUPPLIER. INCOMING INSPECTIONS ARE PERFORMED ACCORDING TO PROCEDURE. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES, NO ISSUES RELATED TO THE REPORTED INCIDENT WERE FOUND. BASED ON THE AVAILABLE INFORMATION, A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS CANNOT BE IDENTIFIED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PIECE OF RUBBER WAS FOUND IN THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "WHEN USING A BD LUER- LOK 30 ML SYRINGE, A PIECE OF RUBBER WAS FOUND IN THE SYRINGE BY THE PHARMACY ASSISTANT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PIECE OF RUBBER WAS FOUND IN THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH: "WHEN USING A BD LUER- LOK 30 ML SYRINGE, A PIECE OF RUBBER WAS FOUND IN THE SYRINGE BY THE PHARMACY ASSISTANT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2295240 BD PLASTIPAK¿ LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2111002

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown