BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE 3 NEEDLES

    MDR report key: 11905479 · Received May 28, 2021

    Report

    Report Number
    3002682307-2021-00220
    Event Type
    Malfunction
    Date Received
    May 28, 2021
    Date of Event
    May 3, 2021
    Report Date
    July 9, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: FOUR PHOTOS OF THE SAMPLE WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE PARTICLES CAN BE OBSERVED IN THE CANNULA SURFACE, CONFIRMING THE CUSTOMER EXPERIENCE. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE TEAM¿S INVESTIGATION AND CONSIDERING THE PREVENTATIVE MEASURES AND CONTROLS IN PLACE DURING THE CANNULA MANUFACTURING PROCESS, THE CORING EFFECT IS UNLIKELY TO BE CAUSE BY POOR OR INSUFFICIENT DE-BURRING PROCESS OF THE CANNULA. THE STOPPER CONDITIONS AND HANDLING MAY HAVE CONTRIBUTED TO THE CORING EFFECT. SINCE MOST OF THE NEEDLES, INCLUDING THE REPORTED ONE, HAVE A SHORT BEVEL, THE NEEDLE SHOULD PENETRATE THE STOPPER AT 90ºC TO MINIMIZE RISK OF CATCHING INTERNAL WALL OF VIAL STOPPER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROLANCE¿ 3 NEEDLE EXPERIENCED FOREIGN MATTER IN OR ON DEVICE CANNULA/NEEDLE/CORING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PHARMACEUTICAL PERSONNEL CLAIMS THAT PARTICLES WERE ATTACHED TO THE CANNULAS DURING THE USE OF BD MICROLANCE 3 CANNULAS, 21 G, LOT 210121. THIS WAS NOTICED AFTER DRAWING UP WITH SOME SYRINGES. WITH CANNULAS FROM OTHER PRODUCERS, THE ISSUE APPEARS SELDOM OR IT CANNOT BE EVEN BE OBSERVED. I TRIED TO GET RID OF THE ¿PARTICLES¿ BY SHAKING ONE OF THE VIALS FILLED WITH ISOTONIC SALINE SOLUTION, BUT WAS NOT SUCCESSFUL. THE ¿PARTICLE¿ CAN BE REMOVED MECHANICALLY. I LIFTED THE CAP TO GET TO THE CANNULA WITHOUT HAVING TO REMOVE THE CANNULA. UNFORTUNATELY, I DO NOT HAVE A MICROSCOPE OR ANY OTHER ANALYTICAL METHODS TO GIVE MORE DETAILS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 BD MICROLANCE¿ 3 NEEDLE EXPERIENCED FOREIGN MATTER IN OR ON DEVICE CANNULA/NEEDLE/CORING. THE FOLLOWING INFORMTION WAS PROVIDED BY THE INITIAL REPORTER: THE PHARMACEUTICAL PERSONNEL CLAIMS THAT PARTICLES WERE ATTACHED TO THE CANNULAS DURING THE USE OF BD MICROLANCE 3 CANNULAS, 21 G, LOT 210121. THIS WAS NOTICED AFTER DRAWING UP WITH SOME SYRINGES. WITH CANNULAS FROM OTHER PRODUCERS, THE ISSUE APPEARS SELDOM OR IT CANNOT BE EVEN BE OBSERVED. I TRIED TO GET RID OF THE ¿PARTICLES¿ BY SHAKING ONE OF THE VIALS FILLED WITH ISOTONIC SALINE SOLUTION, BUT WAS NOT SUCCESSFUL. THE ¿PARTICLE¿ CAN BE REMOVED MECHANICALLY. I LIFTED THE CAP TO GET TO THE CANNULA WITHOUT HAVING TO REMOVE THE CANNULA. UNFORTUNATELY, I DO NOT HAVE A MICROSCOPE OR ANY OTHER ANALYTICAL METHODS TO GIVE MORE DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797583 BD MICROLANCE 3 NEEDLES MICROLANCE NEEDLE FMI BECTON DICKINSON, S.A. 210121

    Patients

    Seq Age Sex Outcome Treatment
    1