BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ 3 NEEDLE

    MDR report key: 8391350 · Received March 5, 2019

    Report

    Report Number
    3002682307-2019-00173
    Event Type
    Malfunction
    Date Received
    March 5, 2019
    Date of Event
    February 11, 2019
    Report Date
    March 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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: 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. NEEDLES WERE PACKED IN MACHINE 2101 (APRIL 3-6TH, 2018) DURING WHICH 70 VISUAL INSPECTIONS WERE CARRIED OUT WITH ZERO DEFECTS NOTED. NEEDLES WERE ASSEMBLED NEEDLES IN MACHINE 4412 AND COME FROM 2 BATCHES: #8078601: (MARCH 20-23RD, 2018) DURING WHICH 177 VISUAL INSPECTIONS OF 25 UNITS EACH WERE PERFORMED WITH ZERO DEFECTS NOTED. #8082597: (APRIL 03-07TH, 2018) DURING WHICH 204 VISUAL INSPECTIONS OF 25 UNITS EACH WERE PERFORMED WITH ZERO DEFECTS NOTED. CANNULA BATCHES #8071800. CONCLUSION(S): SINCE WE WERE UNABLE TO DUPLICATE OR REPRODUCE YOUR INDICATED FAILURE MODE BECAUSE NO SAMPLE HAS BEEN PROVIDE AND REVIEW OF DHR SHOW NO ABNORMALITIES DURING NEEDLES MANUFACTURING, A DEFINITIVE ROOT CAUSE RELATED NEEDLE MANUFACTURING PROCESS IS NOT POSSIBLE TO DETERMINE, AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD MICROLANCE¿ 3 NEEDLE PRODUCT LEAKED OUT BETWEEN THE SYRINGE AND THE NEEDLE WHEN PATIENT INJECTED THE PRODUCT.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 DURING USE OF THE BD MICROLANCE¿ 3 NEEDLE PRODUCT LEAKED OUT BETWEEN THE SYRINGE AND THE NEEDLE WHEN PATIENT INJECTED THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185077 BD MICROLANCE¿ 3 NEEDLE HYPODERMIC NEEDLE FMI BECTON DICKINSON, S.A. 180403

    Patients

    Seq Age Sex Outcome Treatment
    1 Other