BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY

    MDR report key: 7427282 · Received April 12, 2018

    Report

    Report Number
    9610847-2018-00099
    Event Type
    Malfunction
    Date Received
    April 12, 2018
    Date of Event
    January 20, 2018
    Report Date
    April 26, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903096801
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: NO VISUAL DEFECTS WERE DETECTED ON THE SYRINGE. THE COMPLAINT LOTS WERE MANUFACTURED IN A >3 MONTH TIME PERIOD UNDER VARIOUS CONDITIONS USING COMPONENTS THAT WERE NOT COMMON TO EACH LOT. THE MOLDED COMPONENTS WERE MANUFACTURED WITH 9 DIFFERENT MOLDS. THE LEAKAGE IS RANDOM AND THERE ARE NO SPECIFIC TRENDS FOR MOLDS OR CAVITIES WITHIN THE MOLDS. BD DOES NOT BELIEVE THAT THE MANUFACTURING PROCESS IS RELATED TO THE REPORTED LEAKAGE ISSUES. NO CORRECTIVE ACTION IS REQUIRED. ON 18APRIL2018 UPDATE: PROPER USER TECHNIQUE WHEN PREPARING SYRINGES CAN ALSO BE HELPFUL IN PREVENTING THIS SITUATION, ESPECIALLY WITH LARGER SYRINGE SIZES (E.G., 30 ML AND 60 ML). AS A SYRINGE IS BEING FILLED WITH THE VIAL INVERTED AND THE SYRINGE BELOW THE VIAL, THERE MAY BE A TENDENCY TO PULL THE PLUNGER ROD AT AN ANGLE TOWARD THE USER AND NOT ALWAYS MAINTAIN A VERTICAL ALIGNMENT WITH THE SYRINGE BARREL. WITH AN INCREASED AMOUNT OF FLUID IN THE SYRINGE, THE RIBS OF THE STOPPER MAY BE ANGLED ENOUGH TO CAUSE LEAKAGE PAST THE STOPPER RIBS. IT IS ALWAYS IMPORTANT TO ENSURE VERTICAL ALIGNMENT OF THE PLUNGER ROD WITH THE SYRINGE BARREL WHEN WITHDRAWING A SOLUTION USING THIS INVERTED VIAL TECHNIQUE. THE PRACTICE OF STORING MEDICATION WITHIN THE SYRINGE BY THE CUSTOMER IS CONSIDERED AN OFF-LABEL USE. IN ADDITION, ENVIRONMENTAL CONDITIONS DURING SHIPPING OUTSIDE OF BD'S CONTROL MAY HAVE HAD AN UNKNOWN IMPACT ON THE SYRINGES. BOTH FACTORS MAY HAVE CONTRIBUTED TO THE LEAKAGE CONDITION. ON 18APRIL2018 UPDATE: IN ASSESSMENTS BD HAS MADE, LEAKAGE INTO THE AREA BETWEEN THE FIRST AND SECOND RIBS OF THE STOPPER RETAINS THE STERILITY OF THE FLUID AND IN MOST INSTANCES HAS NO IMPACT ON THE VOLUMETRIC ACCURACY OF THE DELIVERY OF THE MEDICATION. A BATCH REVIEW OF THE COMPLAINT LOTS (INCLUDING ALL OF THE AFFECTED COLUMBUS WEST LOTS) WAS CONDUCTED. NO ISSUES AFFECTING LEAKAGE WERE RECORDED DURING THE MANUFACTURING PROCESS. DIMENSIONAL MEASUREMENTS AND FUNCTIONAL TESTING PERFORMED AT THE TIME OF MANUFACTURING WAS ACCEPTABLE. THE COMPLAINT IS NOT CONFIRMED BASED ON THE USE AND CONDITIONS COMMUNICATED BY THE CUSTOMER. THE CUSTOMER REPORTED LEAKAGE FROM OTHER SIZES AND BRANDS OF SYRINGES DURING THE SAME TIME PERIOD AND THE SYRINGES MAY HAVE BEEN SHIPPED IN -30° C WEATHER. THE SYRINGES WERE ALSO USED IN AN OFF-LABEL MANNER VIA STORING MEDICATION.

    Additional Manufacturer Narrative · 1

    TWO POTENTIAL LOT NUMBERS WERE PROVIDED FOR THIS INCIDENT. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS:  MEDICAL DEVICE LOT #: 7242754. MEDICAL DEVICE EXPIRATION DATE: 2022-08-31.  DEVICE MANUFACTURE DATE: 2017-09-25. MEDICAL DEVICE LOT #: 7184875. MEDICAL DEVICE EXPIRATION DATE: 2022-06-30. DEVICE MANUFACTURE DATE: 2017-07-14. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAKAGE WAS FOUND WHILE USING A BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY BETWEEN THE FIRST AND SECOND RIB OF THE STOPPER. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267343 BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY CONVENTIONAL SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SEE SECTION H.10. 30382903096801

    Patients

    Seq Age Sex Outcome Treatment
    1 Other