BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL SYRINGE

    MDR report key: 17857925 · Received October 2, 2023

    Report

    Report Number
    9614033-2023-00119
    Event Type
    Malfunction
    Date Received
    October 2, 2023
    Date of Event
    September 18, 2023
    Report Date
    October 27, 2023
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    00382903033102
    PMA / PMN Number
    K151766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER ADDRESS: (B)(6). H3. 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

    FOUR PHOTOS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, LIQUID CAN BE OBSERVED. IT CAN BE OBSERVED THAT THE SYRINGE IS LUBRICATED WITHIN THE FLUID PATH. IT IS LIKELY THE LUBRICATION IS SILICONE, HOWEVER PHYSICAL SAMPLES ARE REQUIRED TO FURTHER ANALYZE AND CONFIRM. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 3012142, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. LUBRICANT IS EMPLOYED DURING THE SYRINGE ASSEMBLY PROCESS TO LUBRICATE THE CYLINDERS IN THE SILICONE STATION. THE SILICONE EMPLOYED IN THIS PRODUCT IS A MEDICAL GRADE SILICONE AUTHORIZED FOR PRODUCT USE. SILICONE CONTENT TESTS ARE PERFORMED DURING THE MANUFACTURING PROCESS OF EACH LOT NUMBER. BASED ON THE QUALITY TEAM'S INVESTIGATION, A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS CANNOT BE IDENTIFIED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONVENTIONAL SYRINGE HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: THERE HAVE BEEN REPORTS OF A OILY/SILICONE RESIDUE THAT IS INSIDE THESE STERILE 20CC SYRINGES. NOT SURE IF THIS IS HOW THEY COME? I ADDED SOME PICTURES SO YOU CAN SEE FOR YOURSELF, THESE PICTURES WERE TAKEN BY ONE OF THE ANESTHESIA PROVIDERS. NO, ALL THE 20CC APPEAR THAT WAY. BOTH OF OUR BINS IN THE STOCKROOM ARE ALL THAT SAME LOT#. I HAVE LOOKED AT OTHER SIZE SYRINGES AND THEY SEEM TO HAVE A LITTLE OF THAT RESIDUE BUT IN THE BLACK SILICONE PIECE OF IT. THE 20CC DEFINATELY HAS A LOT MORE OF IT. SO, WASN'T SURE IF THIS IS A NORM? AND IF IT IS HOW MUCH IS OK WITHOUT IT BECOMING A PATIENT SAFETY ISSUE

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. # 303310 BATCH# 3012142 VERBATIM: HI ALL, THERE HAVE BEEN REPORTS OF A OILY/SILICONE RESIDUE THAT IS INSIDE THESE STERILE 20CC SYRINGES. NOT SURE IF THIS IS HOW THEY COME? I ADDED SOME PICTURES SO YOU CAN SEE FOR YOURSELF, THESE PICTURES WERE TAKEN BY ONE OF THE ANESTHESIA PROVIDERS BD (BECTON DICKINSON) 20CC SYRINGES CHCO# 191343 REF- (B)(4) LOT- 3012142 PLEASE ADVISE.. XXX / ANESTHESIA TECHNICIAN SPECIALIST / ANESTHESIOLOGY (B)(6) THANKS XXX, I DON¿T THINK THERE SHOULD BE ANY RESIDUE. WAS IT JUST 1 SYRINGE? XXX, MS, RD / VALUE ANALYSIS COORDINATOR / MATERIALS MANAGEMENT ADMIN / (B)(6) NO, ALL THE 20CC APPEAR THAT WAY. BOTH OF OUR BINS IN THE STOCKROOM ARE ALL THAT SAME LOT#. I HAVE LOOKED AT OTHER SIZE SYRINGES AND THEY SEEM TO HAVE A LITTLE OF THAT RESIDUE BUT IN THE BLACK SILICONE PIECE OF IT. THE 20CC DEFINATELY HAS A LOT MORE OF IT. SO, WASN'T SURE IF THIS IS A NORM? AND IF IT IS HOW MUCH IS OK WITHOUT IT BECOMING A PATIENT SAFETY ISSUE PLEASE LET ME KNOW WHAT IS TO FOLLOW XXX / ANESTHESIA TECHNICIAN SPECIALIST / ANESTHESIOLOGY (B)(6) --------- ADD INFO RECEIVED 2ND CUSTOMER RESPONSE THANK YOU FOR STAYING IN TOUCH ABOUT THIS ISSUE! I WAS THE ANESTHESIA PROVIDER ON MONDAY WHO NOTICED THIS CONCERN WITH THE 20CC BD SYRINGES. TO ANSWER YOUR QUESTIONS: ¿ IS SAMPLE AVAILABLE FOR EVALUATION? IF YES, KINDLY PROVIDE THE FACILITY ADDRESS FOR US TO CREATE A RETURN LABEL. - I SAVED SEVERAL SYRINGES IN A BAG, BUT THEY MAY HAVE BEEN ACCIDENTALLY THROWN OUT AT THE END OF THE DAY. I DID TAKE A FEW PICTURES THAT I WILL ATTACH TO THIS EMAIL. ¿ WAS THERE ANY PATIENT INVOLVEMENT? - I WAS DRAWING UP SYRINGES FOR MY SECOND CASE WHEN I NOTICED THIS SILICONE-LIKE SUBSTANCE IN THE SYRINGES. ALL OF THE AFFECTED SYRINGES IN MY DRAWER WERE THEN REMOVED, SO NO HARM REACHED A PATIENT THAT MORNING. ¿ WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? - THERE WAS NO DELAY IN TREATMENT THAT MORNING, BUT I DID HAVE TO SWITCH TO 10 AND 50 ML SYRINGES FOR THE REST OF THE DAY (NOT IDEAL). ¿ WHAT WAS THE MEDICATION/FLUID IN USE AT THE TIME OF THE EVENT? - I DON'T THINK THE CASE TYPE OR FLUID USED ARE RELEVANT TO THIS ISSUE. ¿ IS THE FOREIGN MATTER ABLE TO BE REMOVED OR IS IT EMBEDDED IN THE PLASTIC / NEEDLE? - THE SILICONE-LIKE SUBSTANCE THAT WAS NOTICED IN THE SYRINGES IMMEDIATELY AFTER OPENING THE PACKAGES THEY CAME IN WAS PULLED THROUGH THE SYRINGE WITH THE PLUNGER, THUS LESS NOTICEABLE. THE SUBSTANCE WAS THEN SMEARED THROUGHOUT THE SYRINGE WALLS AND ON THE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1741133 BD CONVENTIONAL SYRINGE PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 3012142 00382903033102

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown