BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ NEEDLE

    MDR report key: 8750061 · Received July 1, 2019

    Report

    Report Number
    3002682307-2019-00382
    Event Type
    Malfunction
    Date Received
    July 1, 2019
    Date of Event
    May 3, 2019
    Report Date
    September 11, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: PROVIDED PICTURES SHOW A GREY ROUND PARTICLE IN FP OF SYRINGE. BD HAS BEEN PROVIDED WITH 2 NEEDLES ASSEMBLED INTO SYRINGES AND PUNCHED IN THE USED MEDICATION VIALS AND 1 NEEDLE IN OPENED PACK OF LOT 190207, NOT THE REPORTED ONE. ONE VIAL SHOWED A GREY ROUND PARTICLE STACKED ON INTERNAL WALL WHICH LOOKS LIKE A VIAL FRAGMENT; WHEN REMOVED NEEDLE FROM THE VIAL RUBBER (IN ORDER TO EXAMINE IN DETAIL THE BEVEL CONDITION) IT WAS OBSERVED AN HUGE HOLE IN THE RUBBER WHICH DOES NOT CORRESPOND TO THE EXPECTED EXPERIENCE AFTER PUNCTURING A REGULAR VIAL. THE SAME WAS DETECTED IN THE OTHER VIAL. ALL RETURNED NEEDLES WERE EXAMINED UNDER MICROSCOPE WITHOUT OBSERVING ANY DAMAGED CANNULA POINT AND WELL-DEBURRED. ALSO, SAMPLES WERE TESTED (USING DIFFERENT ANGLES OF PENETRATION) USING VIAL IN OUR LAB WITH NO DIFFICULTIES AND NO PARTICLES FROM VIALS STOPPER FRAGMENTATION WERE FOUND. HOLE IN STOPPER WERE FOUND AS EXPECTED. BASED ON ABOVE RESULTS AND SINCE DHR SHOW NO EVIDENCE, ABNORMALITIES AND NO ISSUES DURING NEEDLES MANUFACTURING RELATED TO CORING EFFECT (RISK OF CATCHING INTERNAL WALL OF VIAL STOPPER) AND TAKING INTO ACCOUNT THE PREVENTIVE MEASURES AND CONTROLS IN PLACE DURING THE CANNULA MANUFACTURING PROCESS, THE CORING EFFECT IS UNLIKELY TO BE CAUSED BY POOR OR INSUFFICIENT DE-BURRING PROCESS OF THE CANNULA. IN ADDITION, AS A PART OF FRAGA CANNULA INCOMING INSPECTION, VISUAL EXAMINATION (INCLUDING CANNULA POINT CONDITIONS, FLASHES, CLEANLINESS, CLOGGED AND CRASHED CANNULA), MEASUREMENTS AND PENETRATION TEST ARE PERFORMED. NEVERTHELESS, THE STOPPER CONDITIONS AND THE HANDLING CANNOT BE EXCLUDED TO PLAY A ROLE WHICH COULD HAVE SOME POTENTIAL IMPLICATION IN THE CORING EFFECT ISSUES. SINCE MOST OF THE NEEDLES HAVE A SHORT BEVEL LIKE THE REPORTED ONE, THE NEEDLE SHOULD PENETRATE THE STOPPER AT 90º (AS THE RETURNED SAMPLES RECEIVED) TO MINIMIZE RISK OF CATCHING INTERNAL WALL OF VIAL STOPPER. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PLUNGER STOPPER ON THE BD MICROLANCE¿ NEEDLE WAS "PUNCHED OUT" WHILE DRAWING UP MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "DURING PULLING UP A DRUG IT CAME TO PUNCHING OUT THE RUBBER CLOSURE OF THE DRUG VIAL. THE WHOLE THING HAPPENED SEVERAL TIMES."

    Additional Manufacturer Narrative · 1

    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 THE PLUNGER STOPPER ON THE BD MICROLANCE¿ NEEDLE WAS "PUNCHED OUT" WHILE DRAWING UP MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "DURING PULLING UP A DRUG IT CAME TO PUNCHING OUT THE RUBBER CLOSURE OF THE DRUG VIAL. THE WHOLE THING HAPPENED SEVERAL TIMES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542496 BD MICROLANCE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 190204

    Patients

    Seq Age Sex Outcome Treatment
    1 Other