BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 30G NEEDLE

    MDR report key: 12676810 · Received October 21, 2021

    Report

    Report Number
    3002682307-2021-00567
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    September 23, 2021
    Report Date
    September 30, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 190218. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, A PICTURE OF THE AFFECTED SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURE, WHITE FOREIGN MATTER WAS OBSERVED ON THE NEEDLE. THE WHITE MATTER WAS IDENTIFIED AS EPOXY, THE ADHESIVE USED TO JOIN THE CANNULA AND HUB COMPONENTS. BASED ON THE INVESTIGATIVE FINDINGS, THIS DEFECT OCCURRED DURING THE ASSEMBLY PROCESS DUE TO A TEMPORARY MALFUNCTION IN THE EPOXY DOSAGE MACHINE. AS A RESULT OF THIS ERROR, A HIGHER QUANTITY OF EPOXY WAS ADDED AND CONTRIBUTED TO THE OBSERVED DEFECT. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD¿ 30G NEEDLE EXPERIENCED FOREIGN MATTER IN THE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHITE PLASTIC THING ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1569078 BD 30G NEEDLE NEEDLE FMI BECTON DICKINSON, S.A. 190218

    Patients

    Seq Age Sex Outcome Treatment
    1