BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BLUNT FILL NEEDLE

    MDR report key: 9191754 · Received October 15, 2019

    Report

    Report Number
    3002682307-2019-00556
    Event Type
    Malfunction
    Date Received
    October 15, 2019
    Date of Event
    September 30, 2019
    Report Date
    October 23, 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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAS BEEN PROVIDED WITH PHOTOS FOR CATALOG: 303129, LOT: 190608 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION OF THE PHOTOS SHOWS THE FOREIGN MATTER THAT WAS IDENTIFIED AS EPOXY THAT DROPPED ON THE CANNULA SURFACE OF THE NEEDLE. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. BASED ON BD¿S EXPERIENCE, THIS ISSUE OCCURRED IN THE ASSEMBLY PROCESS IN WHICH THE ADHESIVE IS ADDED TO THE HUB POSSIBLY BECAUSE OF SOME TEMPORARY STOPPAGE IN THE PROCESS OR ANY READJUSTMENT OF THE EPOXY DOSAGE STATION. CONSEQUENTLY, HIGHER QUANTITY OF EPOXY WAS ADDED, AND IT FELL TO THE NEXT CANNULA (THE REPORTED ONE) RESULTING IN THE OBSERVED ISSUE DURING THE CURING PROCESS. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. CONCLUSION: EPOXY ADHESIVE FROM ONE NEEDLE TOUCHING THE AFFECTED NEEDLE BEFORE CURING PROCESS. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A HARDENED WHITE SUBSTANCE WAS FOUND ON THE SIDE OF THE BD¿ BLUNT FILL NEEDLE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ONE OF OUR WARDS OPENED A BLUNT DRAWING UP NEEDLE AND FOUND A WHITE SUBSTANCE ON THE SIDE OF THE NEEDLE, ON CLOSER INSPECTION THE WHITE SUBSTANCE WAS HARDENED STAFF NURSE ATTEMPTED TO SCRATCH AND IT PEELED OFF A LITTLE."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 A HARDENED WHITE SUBSTANCE WAS FOUND ON THE SIDE OF THE BD¿ BLUNT FILL NEEDLE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ONE OF OUR WARDS OPENED A BLUNT DRAWING UP NEEDLE AND FOUND A WHITE SUBSTANCE ON THE SIDE OF THE NEEDLE, ON CLOSER INSPECTION THE WHITE SUBSTANCE WAS HARDENED STAFF NURSE ATTEMPTED TO SCRATCH AND IT PEELED OFF A LITTLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984262 BD¿ BLUNT FILL NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 190608

    Patients

    Seq Age Sex Outcome Treatment
    1 Other