BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ NEEDLE

    MDR report key: 8166726 · Received December 14, 2018

    Report

    Report Number
    3002682307-2018-00322
    Event Type
    Malfunction
    Date Received
    December 14, 2018
    Date of Event
    November 30, 2018
    Report Date
    January 18, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    3002682307
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR- ALL THE PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S WERE FOUND. NEEDLES WERE PACKED IN MACHINE 2104 (JULY 26-28TH, 2018) DURING WHICH 52 VISUAL INSPECTIONS WERE CARRIED OUT WITH ZERO DEFECT NOTED. PIC CONFIRM THE DEFECT. BD HAS BEEN PROVIDED WITH 72 SAMPLES OF LOT 180718 AND 1 AFFECTED (CAVITY 6). SAMPLE WAS SENT TO FLKS TO CHARACTERIZE. HOWEVER, FTIR ANALYSIS WAS NOT POSSIBLE TO PERFORM, INDICATING THAT THE MATERIALS ARE METALLIC NATURE. SEM/DEX ANALYSIS WAS COMPLETED RESULTING IT IS MAINLY COMPOSED OF ALUMINUM WITH SMALL AMOUNT OF IRON. CONCLUSION(S): BASED ON THE RESULTS, THE REPORTED ISSUE COULD BE RELATED TO WORN EQUIPMENT OF NEEDLE FEEDER AND IMPROPER CLEANING PROGRAM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ NEEDLES HAD BLACK PARTICLES ON THE NEEDLE.

    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 BD¿ NEEDLES HAD BLACK PARTICLES ON THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003250 BD¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 180718 3002682307

    Patients

    Seq Age Sex Outcome Treatment
    1 Other