BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ 3 NEEDLE

    MDR report key: 8383566 · Received March 1, 2019

    Report

    Report Number
    3002682307-2019-00171
    Event Type
    Malfunction
    Date Received
    March 1, 2019
    Date of Event
    February 14, 2019
    Report Date
    March 12, 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
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: (B)(4): BD HAS REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S. 171218: BD HAS REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NO NCMR'S. THERE WAS ONE REJECTION NOTED RELATED TO SHIEL FLASHES WHICH WOULD NOT AFFECT THE REPORTED ISSUE. BD HAS BEEN PROVIDED WITH ONE OPENED SAMPLE AND TWO EMPTY OPENED UNIT PACK OF LOT (B)(4) AND LOT 180210. VISUAL INSPECTION CONFIRMED SOME WHITE SPOTS ON THE TOP OF CANNULA SURFACE WHICH CONSISTED ON EPOXY (GLUE USED TO JOIN CANNULA INTO HUB). BASED ON ABOVE RESULTS, BD DETERMINED THE FOREIGN MATTER DETECTED BY THE CUSTOMER ARE EPOXY SPOTS (ADHESIVE USED TO JOIN METAL PART WITH NEEDLE PLASTIC PART - HUB). BASED ON OUR EXPERIENCE, THIS ISSUE OCCURRED IN THE ASSEMBLY PROCESS IN WHICH THE ADHESIVE IS ADDED TO THE HUB, PROBABLY BECAUSE OF SOME TEMPORARY STOPPAGE IN THE PROCESS OR ANY READJUSTMENT OF THE EPOXY DOSAGE MACHINE. AS A CONSEQUENCE, HIGHER QUANTITY OF EPOXY WAS ADDED TO AND FELT DOWN TO NEXT CANNULA (THE REPORTED ONE) RESULTING IN THE OBSERVED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHITE FOREIGN MATTER WAS FOUND ON THE BD MICROLANCE¿ 3 NEEDLE BEFORE USE DURING THE "HOTLAB PREPARATIONS". THE NEEDLE WAS REPORTEDLY REMOVED FROM THE PACKAGING "NO MORE THAN FIVE MINUTES" PRIOR AND PLACED IN THE "LAF" CABINET. AS REPORTED BY THE CUSTOMER, TRANSLATED FROM DUTCH TO ENGLISH, "CUSTOMER REPORTED THAT THEY FOUND A NEEDLE WITH A WHITE SUBSTANCE IN THEIR HOTLAB PREPARATIONS. THIS NEEDLE HAD BEEN TAKEN OUT OF THE INDIVIDUAL PACKAGING NO MORE THAN FIVE MINUTES BEFORE AND PLACED IN THE LAF CABINET AND NOT YET USED. SEE THE ATTACHED PICTURES FOR CLARIFICATION. THE NEEDLE MAY COME FROM LOT 1802 10 OR LOT 1712 18. THE NEEDLE IS AVAILABLE FOR INVESTIGATION."

    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 WHITE FOREIGN MATTER WAS FOUND ON THE BD MICROLANCE¿ 3 NEEDLE BEFORE USE DURING THE "HOTLAB PREPARATIONS". THE NEEDLE WAS REPORTEDLY REMOVED FROM THE PACKAGING "NO MORE THAN FIVE MINUTES" PRIOR AND PLACED IN THE "LAF" CABINET. AS REPORTED BY THE CUSTOMER, TRANSLATED FROM DUTCH TO ENGLISH, "CUSTOMER REPORTED THAT THEY FOUND A NEEDLE WITH A WHITE SUBSTANCE IN THEIR HOTLAB PREPARATIONS. THIS NEEDLE HAD BEEN TAKEN OUT OF THE INDIVIDUAL PACKAGING NO MORE THAN FIVE MINUTES BEFORE AND PLACED IN THE LAF CABINET AND NOT YET USED. THE NEEDLE MAY COME FROM LOT 1802 10 OR LOT 1712 18. THE NEEDLE IS AVAILABLE FOR INVESTIGATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174174 BD MICROLANCE¿ 3 NEEDLE HYPODERMIC NEEDLE FMI BECTON DICKINSON, S.A. 180210

    Patients

    Seq Age Sex Outcome Treatment
    1 Other