BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ HYPODERMIC NEEDLE

    MDR report key: 8383565 · Received March 1, 2019

    Report

    Report Number
    3002682307-2019-00170
    Event Type
    Malfunction
    Date Received
    March 1, 2019
    Date of Event
    February 14, 2019
    Report Date
    March 19, 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
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: DURING DHR REVIEW OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NO QN NOR NCMR'S HAS FOUND DURING IN-PROCESS INSPECTIONS. BD HAS BEEN PROVIDED WITH 1 UNIT OF LOT 180415 (CAVITY 12) AND 1 FROM UNKNOWN LOT (CAVITY UNKNOWN). ALL SAMPLES SHOW PAPER RESIDUE PARTIALLY STUCK ON THE FILM AND 2 BROKEN PAPERS. THE FILM AND THE PAPER OF THE UNIT PACK ARE SEALED BY PRESSURE AND TEMPERATURE. BOTH PARAMETERS ARE AUTOMATICALLY CONTROLLED IN THE PROCESS AND VERIFIED BY THE MANUFACTURING OPERATORS. THESE PARAMETERS VALUES HAVE BEEN CHECKED FINDING ALL OF THEM WITHIN SPECIFICATION (PARAMETERS WERE IN NOMINAL STATE). ADDITIONALLY, ABSENCE OF SEALING DEFECT IN THE PRODUCT IS EVALUATED AS PART OF IN-PROCESS INSPECTIONS. SINCE REVIEW OF DHR OF SAMPLE LOT SHOWED NO INDICATION OF THE ALLEGED DEFECT, DESCRIBED ISSUE COULD BE RELATED WITH THE OWN VARIABILITY OF THE TOP WEB PAPER WHICH COULD TEMPORARILY INCREASE THE SEALING FORCE IN THE UNIT PACK (BATCHES OF PAPER AND FILM WERE DIFFERENT IN EACH REPORTED LOT). ON THE OTHER HAND, ALSO THE TECHNIQUE USED FOR OPEN UNITS PACK COULD HAVE SOME POTENTIAL IMPLICATION IN THE ISSUE. BASED ON TESTED SAMPLES AND REVIEW OF DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT, THE ROOT CAUSE WAS POSSIBLE TO BE RELATED WITH USED TECHNIQUE, ESPECIALLY WHEN USING NEEDLES IN CLEAN ROOMS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROLANCE¿ HYPODERMIC NEEDLE PACKAGING OPENED "VERY BADLY", WITH THE PAPER SIDES TEARING THROUGH AND POSING "POTENTIAL STERILITY ISSUES". AS REPORTED BY THE CUSTOMER, TRANSLATED FROM FRENCH TO ENGLISH,"THE SMALL NEEDLES 25G 16MM OPEN VERY BADLY, THE PAPER TEARS. POTENTIAL STERILITY ISSUES I ENCOUNTERED THIS PROBLEM FOR ABOUT A MONTH."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD MICROLANCE¿ HYPODERMIC NEEDLE PACKAGING OPENED "VERY BADLY", WITH THE PAPER SIDES TEARING THROUGH AND POSING "POTENTIAL STERILITY ISSUES". AS REPORTED BY THE CUSTOMER, TRANSLATED FROM FRENCH TO ENGLISH,"THE SMALL NEEDLES 25G 16MM OPEN VERY BADLY, THE PAPER TEARS. POTENTIAL STERILITY ISSUES I ENCOUNTERED THIS PROBLEM FOR ABOUT A MONTH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174156 BD MICROLANCE¿ HYPODERMIC NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other