BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ NEEDLE

    MDR report key: 8055237 · Received November 9, 2018

    Report

    Report Number
    3002682307-2018-00281
    Event Type
    Malfunction
    Date Received
    November 9, 2018
    Date of Event
    October 25, 2018
    Report Date
    November 15, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903040001
    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: DHR-NEEDLES WERE PACKED IN MACHINE Nº2101 (MARCH 25-30TH, 2017) DURING WHICH 92 VISUAL INSPECTION OF 100 UNITS EACH WERE CARRIED OUT WITH ZERO DEFECTS NOTED. NEEDLES WERE ASSEMBLED IN MACHINE Nº 4412 AND COME FROM 2 BATCHES: -#7066137 (MARCH 13-21ST, 2017) DURING WHICH 351 VISUAL INSPECTION OF 25 UNITS EACH WERE CARRIED OUT WITH 0 REJECTION NOTED. -#7076464 (MARCH 21-30TH, 2017) DURING WHICH 277 VISUAL INSPECTION OF 25 UNITS EACH WERE CARRIED OUT WITH ZERO DEFECTS NOTED. CANNULA BATCHES: 6231408, 6239204 AND 6259034. SINCE DHR REVIEW SHOW NO ABNORMALITIES AND DEFECT IS NOT CONFIRMED SINCE NO SAMPLE OR PICTURE HAS BEEN PROVIDED, NO CORRECTION ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD MICROLANCE¿ NEEDLE BROKE DURING USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). INITIAL REPORTER OCCUPATION OTHER: QUALITY ASSURANCE ENGINEER. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD MICROLANCE¿ NEEDLE BROKE DURING USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897302 BD MICROLANCE¿ NEEDLE HYPODERMIC NEEDLE FMI BECTON DICKINSON, S.A. 170326 00382903040001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other