BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE ULTRA 4MM

    MDR report key: 12418864 · Received September 2, 2021

    Report

    Report Number
    9616656-2021-01087
    Event Type
    Malfunction
    Date Received
    September 2, 2021
    Date of Event
    August 5, 2021
    Report Date
    August 23, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: SEVEN PHOTOS OF A 32G X 4MM PEN NEEDLE CARTON WERE RETURNED FROM LOT. NO. 9114935, CAT. NO. 320497. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED PHOTOS AND A LABEL WHICH IS NOT APPLIED DURING THE MANUFACTURING PROCESS WAS OBSERVED ON THE CARTONS. NO MIXED PRODUCT WAS OBSERVED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. BASED ON THE PHOTOS RETURNED THIS CANNOT BE CONFIRMED TO BE MANUFACTURING RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT INSIDE THE BD MICRO-FINE ULTRA¿ 4MM WAS ACTUALLY THE BD MICRO FINE PLUS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER CALLED TO DISCUSS THE DIFFERENCE BETWEEN THE BD MICRO-FINE ULTRA AND THE BD MICRO-FINE PLUS PEN NEEDLES AS HE HAS RECEIVED A PRESCRIPTION THAT WAS A BOX LABELED MICRO-FINE ULTRA BUT INSIDE THE PACKAGING WAS BD MICRO-FINE PLUS PEN NEEDLES. ON THE BOX IT STATES THAT THESE ORIGINATE FROM FRANKLIN LAKES USA BUT HAVE BEEN RE-LABELLED "PROCURED FROM WITHIN THE EU AND RE-PACKAGED BY AFREMED LTD, W18 3HH" THE PCN ON THE PACKAGING IS 320497 WITH PIP CODE (B)(4). ADVISED THAT HE WOULD NEED TO ALSO SPEAK TO PHARMACIST REGARDING THIS DISCREPANCY. CUSTOMER WILL BE SENDING PICTURES OF ALL SIDES OF OUTER PACKAGING SO WE CAN IDENTIFY WHERE THE PRODUCT ORIGINATED FROM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1316501 BD MICRO-FINE ULTRA 4MM HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 9114935

    Patients

    Seq Age Sex Outcome Treatment
    1