BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE W/O NEEDLE

    MDR report key: 7245567 · Received February 6, 2018

    Report

    Report Number
    3002682307-2018-00019
    Event Type
    Malfunction
    Date Received
    February 6, 2018
    Date of Event
    January 11, 2018
    Report Date
    January 25, 2018
    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
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: SAMPLE EVALUATION: WE HAVE BEEN PROVIDED WITH THE AFFECTED SAMPLE. A LEAKAGE THROUGH THE PLUNGER ROD WAS OBSERVED IN THIS PROVIDED SAMPLE. AFTER THAT WE COULD DETERMINATE DAMAGED IN THE PLUNGER ROD BY THE EVALUATION OF THE PLUNGER WITH MAGNIFICATION. BHR REVIEW WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QA NOR NCMR'S. SYRINGES WERE PACKED IN MACHINE Nº2022 (SEPTEMBER 16 - 17TH, 2016). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4252, Nº4251, Nº4208, AND Nº4204, IN LOT #6242446 (AUGUST 29TH - SEPTEMBER 5TH, 2016), AND IN LOT #6256229 (SEPTEMBER 12 - 19TH, 2016). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #6239275, #6230486, #6253443, AND #6249467 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #6239284, #6230008, #6253447, AND #6249472 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. ROOT CAUSE ANALYSIS WE CONCLUDE THAT THE CAUSE OF THE PROBLEM WAS PRODUCED AS A CONSEQUENCE OF A DAMAGE IN THE PLUNGER LIP. THIS COULD BE PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR IN THE PLUNGER ASSEMBLY MACHINE. CONFIRMATION. THE PROVIDED SAMPLE PRESENTED THE REPORTED ISSUE. WE COULD CONFIRM THE REPORTED ISSUE. CAPA DETERMINATION. NO - BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINATE THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINATE THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BD DISCARDIT¿ II SYRINGE W/O NEEDLE PLUNGER ROD WAS BROKEN AND DEFECTIVE. THE EVENT OCCURED DURING PREPARATION, BEFORE INJECTION. CAUSING LEAK AND LOSS OF ANTIBIOTICS. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89380 BD DISCARDIT¿ II SYRINGE W/O NEEDLE SYRINGE FMF BECTON DICKINSON, S.A. 1609236

    Patients

    Seq Age Sex Outcome Treatment
    1 Other