BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ 3 NEEDLE

    MDR report key: 17056368 · Received June 2, 2023

    Report

    Report Number
    3002682307-2023-00147
    Event Type
    Malfunction
    Date Received
    June 2, 2023
    Date of Event
    April 18, 2023
    Report Date
    September 12, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 26-JUN-2023. H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301500 AND LOT NUMBER 220819. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, TEN (10) UNUSED NEEDLE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THE NEEDLES WERE EXAMINED UNDER A MICROSCOPE AND NO DAMAGE WAS OBSERVED TO THE BEVEL. THE NEEDLES WERE TESTED USING A LABORATORY VIAL WITH A PLASTIC STOPPER; HOWEVER, NO DIFFICULTIES WERE DETECTED. AFTER VIAL PUNCTURE TESTING, THE NEEDLES WERE AGAIN EXAMINED UNDER MICROSCOPE AND NO PARTICLES FROM VIAL STOPPER FRAGMENTATION WERE FOUND AND THE BEVELS REMAINED IN GOOD FORM. BASED ON THE PREVENTIVE MEASURES IN PLACE, IT IS UNLIKELY THAT THE CORING EFFECT RESULTED FROM POOR OR INSUFFICIENT DE-BURRING OF THE CANNULA DURING MANUFACTURE.

    Additional Manufacturer Narrative · 0

    H.3. 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 · 0

    IT WAS REPORTED THAT THE BD MICROLANCE¿ 3 NEEDLE CORED A PIECE OF THE VIAL STOPPER INTO THE MEDICATION AFTER MIXING THE ULITVA AND SALINE. THIS OCCURRED WITH 2 NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NEEDLE HAD PUNCHED OUT A PIECE OF RUBBER. AFTER MIXING AN AMPOULE OF ULITVA WITH SALINE, I DISCOVERED THAT THE NEW TYPE OF WITHDRAWAL NEEDLE HAD PUNCHED OUT A PIECE OF RUBBER FROM THE MEMBRAN ON THE ULTIVA BOTTLE. PULLED UP THE MEDICINE WITH A NEEDLE WITH FILTER DURING USE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROLANCE¿ 3 NEEDLE CORED A PIECE OF THE VIAL STOPPER INTO THE MEDICATION AFTER MIXING THE ULITVA AND SALINE. THIS OCCURRED WITH 2 NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NEEDLE HAD PUNCHED OUT A PIECE OF RUBBER. AFTER MIXING AN AMPOULE OF ULITVA WITH SALINE, I DISCOVERED THAT THE NEW TYPE OF WITHDRAWAL NEEDLE HAD PUNCHED OUT A PIECE OF RUBBER FROM THE MEMBRAN ON THE ULTIVA BOTTLE. PULLED UP THE MEDICINE WITH A NEEDLE WITH FILTER DURING USE"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218297 BD MICROLANCE¿ 3 NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 220819

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown