BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 13385408 · Received January 28, 2022

    Report

    Report Number
    3003152976-2022-00032
    Event Type
    Malfunction
    Date Received
    January 28, 2022
    Date of Event
    January 8, 2022
    Report Date
    March 11, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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: D10: DEVICE AVAILABLE FOR EVAL? YES. D10: RETURNED TO MANUFACTURER ON: 2022-FEB-01. H6: INVESTIGATION SUMMARY: TWO SAMPLES AND ONE PHOTO WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON INSPECTING THE PRODUCT, IT WAS OBSERVED THAT THE LIQUID INSIDE EACH SYRINGE DIFFERS IN COLOR. 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. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOTS 2009023 AND 2110092, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. ALL PRODUCTS LABELED AS "STERILE" ARE CERTIFIED FOR RELEASE, THE PACKAGE MUST BE UNOPENED AND UNDAMAGED. STERILIZATION RECORDS VERIFIED THE PRODUCT WAS PROPERLY STERILIZED ACCORDING TO PROCEDURE, NO ISSUES OR DEVIATIONS OCCURRED DURING THIS PROCESS. EVALUATIONS ARE PERFORMED TO EVALUATE REMAINING ETHYLENE OXIDE RESIDUES AFTER STERILIZATION. ALL RECORDS FOR LOTS 2009023 AND 2110092 WERE FOUND TO BE WITHIN THE REQUIRED LIMITS. THERE HAVE BEEN NO CHANGES IN THE MANUFACTURING PROCESS OR MATERIALS USED TO MANUFACTURE THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. BASED UPON THE AVAILABLE INFORMATION, WE WERE UNABLE TO DETERMINE A ROOT CAUSE RELATED TO THE SYRINGE OR OUR MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE EXPERIENCED DISCOLORATION OF THE SOLUTION AFTER BEING DRAWN INTO THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE LIQUID WAS FIRST READY, BUT AFTER A FEW HOURS WHEN THE INFUSION WAS READY TO BEGIN, THE PREPARATION WAS DARK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE EXPERIENCED DISCOLORATION OF THE SOLUTION AFTER BEING DRAWN INTO THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE LIQUID WAS FIRST READY, BUT AFTER A FEW HOURS WHEN THE INFUSION WAS READY TO BEGIN, THE PREPARATION WAS DARK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1751530 BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2110092

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown