BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ 3 NEEDLE

    MDR report key: 13542994 · Received February 16, 2022

    Report

    Report Number
    3002682307-2022-00055
    Event Type
    Malfunction
    Date Received
    February 16, 2022
    Date of Event
    January 20, 2022
    Report Date
    February 28, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    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 210502. 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, PICTURE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURES, A NEEDLE WITH DROPS OF EPOXY WAS OBSERVED. EPOXY IS THE ADHESIVE USED TO JOIN THE CANNULA AND HUB COMPONENTS. WE HAVE CONCLUDED THAT THIS ISSUE OCCURRED DURING THE ASSEMBLY PROCESS WHEN THE EPOXY IS ADDED, DUE TO A TEMPORARY STOPPAGE OR MALFUNCTION IN THE EPOXY DOSAGE MACHINE. CONSEQUENTLY, A HIGHER QUANTITY OF EPOXY WAS ADDED AND DROPPED ONTO THE AFFECTED CANNULA. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED BD MICROLANCE¿ 3 NEEDLE HAD EPOXY ON THE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN UNPACKING THE NEEDLE, IT IS SEEN THAT ON THE NEEDLE'S TIP THERE IS WHITE GLUE."

    Description of Event or Problem · 0

    IT WAS REPORTED BD MICROLANCE¿ 3 NEEDLE HAD EPOXY ON THE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN UNPACKING THE NEEDLE, IT IS SEEN THAT ON THE NEEDLE'S TIP THERE IS WHITE GLUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529912 BD MICROLANCE¿ 3 NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 210502

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown