BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO FINE ULTRA PRO 4MM

    MDR report key: 15259724 · Received August 19, 2022

    Report

    Report Number
    2243072-2022-01379
    Event Type
    Malfunction
    Date Received
    August 19, 2022
    Date of Event
    July 22, 2022
    Report Date
    August 10, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THERE ARE MULTIPLE BD LOCATIONS WHERE THIS BD DEVICE MAY HAVE BEEN MANUFACTURED. A LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED IN SECTIONS MANUFACTURER NAME, CITY AND STATE AND MFR SITE AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE LOT #: AN INVALID LOT # OF 5040925 WAS PROVIDED BY THE INITIAL REPORTER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A COMPLAINT LOT HISTORY CHECK WAS PERFORMED ON LOT # 5040925 FOR NEEDLE CLOG. THIS IS THE 1ST. RELATED COMPLAINT FOR NEEDLE CLOG ON LOT # 5040925. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SEVERAL BD MICRO FINE ULTRA PRO 4MM WERE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: PATIENT COMPLAINED THAT HER 4MM PEN NEEDLES HAVE BEEN CLOGGED SEVERAL TIMES AND SHE CAN'T USE THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2070040 BD MICRO FINE ULTRA PRO 4MM HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown