BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN PEN NEEDLE

    MDR report key: 7400801 · Received April 5, 2018

    Report

    Report Number
    9616657-2018-00014
    Event Type
    Malfunction
    Date Received
    April 5, 2018
    Date of Event
    March 22, 2018
    Report Date
    May 11, 2018
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED ONE SEALED/NOT USED 4MM, 32G BD PEN NEEDLE. CUSTOMER REPORTED PEN NEEDLE CAP WAS DAMAGED; IT HAD A PIECE OF PLASTIC COMING OUT OF IT. THE RETURNED PEN NEEDLE WAS EXAMINED AND IT EXHIBITED A BROKEN OUTER COVER. A LOT HISTORY REVIEW FOR LOT 7200601 CAT NO. 320122 WAS CARRIED OUT AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THE PACKAGED LOT OR THE SUB-ASSEMBLY CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE - BROKEN OUTER COVER. UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE - FOREIGN MATTER. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME FOR FM AS THE ISSUE IS UNCONFIRMED. UNABLE TO DETERMINE ROOT CAUSE FOR BROKEN OUTER COVER.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: N/A. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PEN NEEDLE CAP OF THE BD ULTRA-FINE¿ INSULIN PEN NEEDLE WAS DAMAGED PRIOR TO USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED. CONSUMER STATES; ¿THE PLASTIC CAP THAT YOU REMOVE WHEN PUTTING THE PEN NEEDLE ONTO THE PEN HAD A PIECE OF PLASTIC COMING OUT OF IT, THE OUTER COVER IS DAMAGED.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244432 BD ULTRA-FINE¿ INSULIN PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON AND CO. 7200601

    Patients

    Seq Age Sex Outcome Treatment
    1 Other