BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SPECIALTY SYRINGES AND ACCESSORIES (FLU+SYRINGE 0.25-1ML)

    MDR report key: 7014742 · Received November 9, 2017

    Report

    Report Number
    3002682307-2017-00087
    Event Type
    Malfunction
    Date Received
    November 9, 2017
    Date of Event
    September 29, 2017
    Report Date
    November 28, 2017
    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
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: 40 RETAINED SAMPLES FOR EACH BATCH HAVE BEEN EVALUATED CONFIRMING NO PRESENCE OF FM IN THE SYRINGES. COMPLAINT TRENDING REVIEW OF THIS LOT FOR THIS ISSUE REVEALS 1 COMPLAINT (INCLUDING THIS ONE). OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NO QN NOR NCMR'S HAS FOUND DURING IN-PROCESS INSPECTIONS. SYRINGES WERE PACKED IN MACHINE Nº2014 (JUNE 21-23RD, 2013) DURING WHICH 19 VISUAL INSPECTIONS OF 100 UNITS EACH WERE CARRIED OUT WITH ZERO DEFECTS NOTED. SYRINGES (#3162067) WERE ASSEMBLED AND PRINTING IN MACHINE Nº4246 (JUNE 18-23RD, 2013) DURING WHICH VISUAL 111 INSPECTIONS WERE CARRIED OUT WITH ZERO DEFECTS NOTED. SYRINGES (#3162065) WERE CANNULATED IN MACHINE Nº4102 (JUNE 17-23RD, 2013) DURING WHICH 239 VISUAL INSPECTIONS WERE CARRIED OUT WITH ZERO DEFECTS NOTED. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE. CUSTOMER COMPLAINT IS RELATED TO FOREIGN MATTER AND CONFIRMED THANKS TO RETURNED PICTURES. ROOT CAUSE: BASED ON REVIEW OF PRODUCT HISTORY, WHICH SHOWED NO INDICATION OF THE ALLEGED DEFECT OR ABNORMALITIES DURING PRODUCTION, NO OTHER COMPLAINTS HAS BEEN RECEIVED FROM REPORTED BATCHES AND AFTER TALK WITH TECHNICIANS IN CHARGE OF LINES, A DEFINITIVE ORIGIN OF THE DETECTED FOREIGN MATTER WITHOUT AFFECTED SAMPLE IS NOT POSSIBLE TO DETERMINATE AT THIS TIME. THE AVAILABILITY OF THE AFFECTED SAMPLE WOULD BE A KEY ELEMENT IN ORDER TO DETERMINE THE ROOT CAUSE. TAKING INTO ACCOUNT AVAILABLE PICTURES, TWO POSSIBLE ROOT CAUSES COULD BE POINTED OUT: *MINOR MARKS OF INK FROM THE MARKING PROCESS OF BD FLU+ SYRINGES, WHICH IS AN APPROVED AND HIGH CAPABLE PRINTING TECHNOLOGY FOR MEDICAL DEVICES, BUT IS SOME CIRCUMSTANCES THERE IS A POSSIBILITY THAT DURING THE SCALE STAMPING SOME MINOR INK SPECK COULD COME OFF REMAINING ATTACHED TO THE SURFACE OF THE BARREL. THE PRESENCE OF THESE INK SPECKS SHOULD BE VERY LIMITED AND ALWAYS IN A VERY SMALL SIZE, NORMALLY INAPPRECIABLE UNDER NORMAL VISUAL CONDITIONS. IT IS CONCLUDED THAT THE RISK ASSOCIATED TO THIS ISSUE SHOULD BE VERY LOW AND NEGLIGIBLE AND SHOULD NOT REPRESENT ANY IMPACT TO THE HEALTH OF THE PATIENT OR USER. EMBEDDED PARTICLE OF BURNT PLASTIC COMING FROM THE POLYPROPYLENE WHICH IS EMBEDDED IN THE PLASTIC WALL OF THE SYRINGE. THIS DEFECT WAS PRODUCED IN THE SCREW OF THE INJECTION MOLDING MACHINE AND IT IS A INHERENT ISSUE OF MOLDING PROCESSES. DUE TO THE HIGH WORKING TEMPERATURES, SOME PARTICLES OF PLASTIC CAN REMAIN STUCK ON THE INTERNAL WALLS OF THE MOLD, GET BURNT AND IN ISOLATED CASES, IT MAY BE DETACHED FROM THE SCREW BEING INJECTED AND REMAINING EMBEDDED IN THE PIECE. HOWEVER, THIS IS A COSMETIC DEFECT WHICH HAVE NO RISK AT ALL TO THE HEALTH BECAUSE THE BURNT PLASTIC IS TRAPPED IN THE PLASTIC OF THE BARREL WITHOUT POSSIBILITY OF BEING DETACHED FROM IT. THE HIGHLY CAPABLE PROCESS EMPLOYED BY BD TO PRODUCE MEDICAL DEVICES KEEPS FOREIGN MATTER AT EXTREMELY LOW LEVELS THROUGH STRINGENTLY CONTROLLED MANUFACTURING PROCESSES, SAMPLING PLAN AND ENVIRONMENTAL CONTROLS. IN BD FRAGA, THE WHOLE PROCESS FROM ASSEMBLY TO PACKAGING THE PRODUCT TAKES PLACE IN AN ENVIRONMENTALLY CONTROLLED ROOM WHERE GOOD MANUFACTURING PRACTICES ARE STRICTLY FOLLOWED. BASED ON AN EVALUATION OF SEVERITY, OCCURRENCE AND SINCE NO ADVERSE EVENT TOOK PLACE, IT WAS DETERMINATED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS NOT AVAILABLE FOR EVALUATION. HOWEVER, A NO SAMPLE INVESTIGATION AND DEVICE HISTORY RECORD REVIEW WILL BE COMPLETED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND INSIDE THE BARREL OF A BD¿ SPECIALTY SYRINGES AND ACCESSORIES (TRAY TIP CAP) SYRINGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795542 BD¿ SPECIALTY SYRINGES AND ACCESSORIES (FLU+SYRINGE 0.25-1ML) SYRINGE FMF BECTON DICKINSON, S.A. 1306419

    Patients

    Seq Age Sex Outcome Treatment
    1 Other