BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 20ML SYRINGE LUER-LOK

    MDR report key: 11468125 · Received March 11, 2021

    Report

    Report Number
    3003152976-2021-00136
    Event Type
    Malfunction
    Date Received
    March 11, 2021
    Date of Event
    February 12, 2021
    Report Date
    April 21, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: (B)(6) 2021. INVESTIGATION SUMMARY: ONE PHOTO AND ONE PHYSICAL SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION OF THE PRODUCT, NO DAMAGE, MOLDING DEFECTS, OR ASSEMBLY ISSUES WERE OBSERVED ON THE SYRINGE OR ANY OF THE SYRINGE COMPONENTS. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2010034, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. 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. BASED ON THE SAMPLE EVALUATION AND OUR QUALITY TEAM'S INVESTIGATION, NO DEFECTS WERE IDENTIFIED THEREFORE, WE CANNOT DETERMINE A ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ 20ML SYRINGE LUER-LOK¿ EXPERIENCED INCORRECT POSITIONING OF THE PLUNGER ROD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SYRINGE HAS ITS PISTON OUT OF ALIGNMENT.

    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¿ 20ML SYRINGE LUER-LOK¿ EXPERIENCED INCORRECT POSITIONING OF THE PLUNGER ROD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SYRINGE HAS ITS PISTON OUT OF ALIGNMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355439 BD PLASTIPAK 20ML SYRINGE LUER-LOK SYRINGE FMF BECTON DICKINSON, S.A. 2010034

    Patients

    Seq Age Sex Outcome Treatment
    1