BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGE WITH DETACHED BD MICROLANCE¿ 3 NEEDLE

    MDR report key: 13514188 · Received February 11, 2022

    Report

    Report Number
    3003152976-2022-00061
    Event Type
    Malfunction
    Date Received
    February 11, 2022
    Date of Event
    January 24, 2022
    Report Date
    March 28, 2022
    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
    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

    INVESTIGATION SUMMARY: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2111146, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THE NEEDLES ASSEMBLED ONTO THIS SYRINGE ARE PROVIDED BY AN EXTERNAL SUPPLIER. INCOMING INSPECTIONS ARE ROUTINELY PERFORMED, NO ISSUES WERE IDENTIFIED ON THE INSPECTION REPORTS. 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. ALL INSPECTIONS FOR LOT 2111146 WERE COMPLETED ACCORDING TO PROCEDURE, NO ANNOTATIONS WERE NOTED RELATED TO THE REPORTED INCIDENT. RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR DEFECTS WAS OBSERVED ON ANY OF THE NEEDLES AND ALL DIMENSIONS WERE VERIFIED TO BE WITHIN REQUIRED SPECIFICATIONS. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT HEPARIN LEAKED FROM THE BD PLASTIPAK¿ SYRINGE WITH DETACHED BD MICROLANCE¿ 3 NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "1 ML SYRINGE PRE-ASSEMBLED WITH A NEEDLE SIZE OF 10 MM IN LENGTH WHICH NO LONGER ALLOWS THE ENTIRE INJECTION SITE OF THE HEMODIALYSIS LINES TO BE PERFORATED, CAUSING HYPERPRESSURE AND PROJECTIONS DUE TO THE HYPERPRESSURE IN THE FACE PROFESSIONALS BY MISMATCHING THE NEEDLE OF THE SYRINGE. SPLASH OF HEPARIN IN THE EYES OF THE AGENTS AND NO COMPLETE ADMINISTRATION OF ANTICOAGULANT IN THE HEMODIALYSIS LINES NEEDLE TOO SHORT 10 MM WHICH DOES NOT ALLOW THE SITE OF THE LINES OF DIALYSIS TO BE PERFORATED OLD NEEDLE AT 17 MM."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT HEPARIN LEAKED FROM THE BD PLASTIPAK¿ SYRINGE WITH DETACHED BD MICROLANCE¿ 3 NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "1 ML SYRINGE PRE-ASSEMBLED WITH A NEEDLE SIZE OF 10 MM IN LENGTH WHICH NO LONGER ALLOWS THE ENTIRE INJECTION SITE OF THE HEMODIALYSIS LINES TO BE PERFORATED, CAUSING HYPERPRESSURE AND PROJECTIONS DUE TO THE HYPERPRESSURE IN THE FACE PROFESSIONALS BY MISMATCHING THE NEEDLE OF THE SYRINGE. SPLASH OF HEPARIN IN THE EYES OF THE AGENTS AND NO COMPLETE ADMINISTRATION OF ANTICOAGULANT IN THE HEMODIALYSIS LINES NEEDLE TOO SHORT 10 MM WHICH DOES NOT ALLOW THE SITE OF THE LINES OF DIALYSIS TO BE PERFORATED OLD NEEDLE AT 17 MM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91215 BD PLASTIPAK¿ SYRINGE WITH DETACHED BD MICROLANCE¿ 3 NEEDLE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2111146

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown