BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ NEEDLE

    MDR report key: 15376004 · Received September 8, 2022

    Report

    Report Number
    3002682307-2022-00231
    Event Type
    Malfunction
    Date Received
    September 8, 2022
    Date of Event
    August 29, 2022
    Report Date
    September 28, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304622 AND LOT NUMBER 220329. 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, TWO PICTURE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURES, A DROP OF EPOXY WAS OBSERVED ON THE HUB COMPONENT. EPOXY IS THE WHITE ADHESIVE USED TO JOIN THE CANNULA AND THE HUB COMPONENTS TOGETHER. THIS DEFECT RESULTED DURING THE ASSEMBLY PROCESS DUE TO A TEMPORARY STOPPAGE OR MALFUNCTION IN THE EPOXY DOSAGE MACHINE. CONSEQUENTLY, A HIGHER QUANTITY OF EPOXY WAS ADDED AND FELL ONTO THE AFFECTED HUB COMPONENT; RESULTING IN THE DEFECT OBSERVED. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. 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 · 0

    IT WAS REPORTED THAT THE BD MICROLANCE¿ NEEDLE HAD FOREIGN MATTER ON IT WHEN REMOVING IT FROM THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DIRTY WHEN OPENING THE PACKAGE THE NEEDLE WAS DIRTY"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROLANCE¿ NEEDLE HAD FOREIGN MATTER ON IT WHEN REMOVING IT FROM THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DIRTY WHEN OPENING THE PACKAGE THE NEEDLE WAS DIRTY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325545 BD MICROLANCE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 220329

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown