BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE HYPODERMIC NEEDLE

    MDR report key: 10336351 · Received July 28, 2020

    Report

    Report Number
    3002682307-2020-00232
    Event Type
    Malfunction
    Date Received
    July 28, 2020
    Date of Event
    July 6, 2020
    Report Date
    August 6, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 190315 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE PICTURE SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURE SAMPLE, THE CANNULA APPEARED SHORTER AND WITHOUT A POINT. IT IS POSSIBLE THAT THIS INCIDENT RESULTED FROM AN ERROR IN THE CANNULA CUTTING PROCESS, BEFORE THE CANNULA POINT IS FORMED. DURING THE CANNULA TUBING CUTTING PROCESS, THE AUTOMATIC CUTTING MACHINE CONSISTENTLY CUTS THE CANNULA TUBING THAT IS STILL WITHIN THE MACHINE, WHICH MAY RESULT IN RESIDUAL TUBING THAT IS SHORTER THAN SPECIFICATION. IF THE RESIDUAL MATERIAL IS NOT DISCARDED, IT WILL MOVE THROUGH THE NEXT STEP OF THE PRODUCTION PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROLANCE¿ HYPODERMIC NEEDLE WAS BROKEN DURING USE AND HURT A PATIENT WHEN THEY WERE INJECTED WITH IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UNFORTUNATELY I HAVE TO REPORT THAT A PATIENT GOT HURT BECAUSE SHE WAS INJECTED WITH A BROKEN/SHORT NEEDLE."

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD MICROLANCE HYPODERMIC NEEDLE WAS BROKEN DURING USE AND HURT A PATIENT WHEN THEY WERE INJECTED WITH IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UNFORTUNATELY I HAVE TO REPORT THAT A PATIENT GOT HURT BECAUSE SHE WAS INJECTED WITH A BROKEN/SHORT NEEDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800494 BD MICROLANCE HYPODERMIC NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 190315

    Patients

    Seq Age Sex Outcome Treatment
    1 Other