BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE WITH NEEDLE

    MDR report key: 7534661 · Received May 22, 2018

    Report

    Report Number
    3002682307-2018-00122
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Date of Event
    May 7, 2018
    Report Date
    May 14, 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
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: BD HAS BEEN PROVIDED WITH A PICTURE AND THE AFFECTED SAMPLE FOR THE INVESTIGATION OF THIS RECORD. THE EVALUATION OF THE SAMPLE SHOWED THE PRESENCE OF A DARK MARK EMBEDDED IN THE SYRINGE BARREL. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. THE PARTICLES IDENTIFIED BY THE CUSTOMER, WERE ACTUALLY A BURNT PART OF THE SYRINGE BARREL, PRODUCED IN THE SCREW OF THE INJECTION MOLDING MACHINE. DUE TO THE HIGH WORKING TEMPERATURES (ABOUT 300ºC), DUE TO A PUNCTUAL INCREASE OF THIS CONDITIONS, THE BARREL OF THIS SYRINGE GOT BURNT DURING THE PROCESS AND A DARK MARK REMAINED IN THE PIECE. THIS A COSMETIC DEFECT WHICH HAS NO RISK TO THE HEALTH OF THE PATIENT. BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE, IT WAS DETERMINATE THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. SAMPLE EVALUATION WE HAVE BEEN PROVIDED WITH A PICTURE AND THE AFFECTED SAMPLE. THE EVALUATION OF THE SAMPLE SHOWED THE PRESENCE OF A DARK MARK EMBEDDED IN THE SYRINGE BARREL. THAT CONFIRMED THE REPORTED ISSUE. 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 (B)(4) (MARCH 16 - 18TH, 2017). SYRINGES WERE ASSEMBLED IN MACHINE, (B)(4), IN LOT #7072499 (MARCH 13TH - 20TH, 2017). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #7072482, #7062448, AND #7055054 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7072486, AND #7062449 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. ROOT CAUSE ANALYSIS: THE PARTICLES IDENTIFIED BY THE CUSTOMER, WERE ACTUALLY A BURNT PART OF THE SYRINGE BARREL, PRODUCED IN THE SCREW OF THE INJECTION MOLDING MACHINE. DUE TO THE HIGH WORKING TEMPERATURES (ABOUT 300ºC), DUE TO A PUNCTUAL INCREASE OF THIS CONDITIONS, THE BARREL OF THIS SYRINGE GOT BURNT DURING THE PROCESS AND A DARK MARK REMAINED IN THE PIECE. THIS A COSMETIC DEFECT WHICH HAS NO RISK TO THE HEALTH OF THE PATIENT. CONFIRMATION: THE RETURNED SAMPLE PRESENTED EMBEDDED FOREIGN MATTER IN THE BARREL. WE CONFIRMED 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN A BD¿ SYRINGE WITH NEEDLE. THE DEVICE WAS NOT USED AND THERE WAS NOT REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378225 BD¿ SYRINGE WITH NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON, S.A. 1703190

    Patients

    Seq Age Sex Outcome Treatment
    1 Other