BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 6MM 3B TW 70CT JPN

    MDR report key: 10723102 · Received October 22, 2020

    Report

    Report Number
    9616656-2020-01053
    Event Type
    Malfunction
    Date Received
    October 22, 2020
    Date of Event
    October 2, 2020
    Report Date
    November 12, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: FOUR OPEN AND 63 SEALED 32G X 6MM PEN NEEDLE SAMPLES AND FOUR PHOTOS WERE RETURNED FROM LOT. NO. 9121516, CAT. NO. 320738. A CLOG TEST WAS CARRIED OUT ON THE FOUR OPEN SAMPLES AND TWENTY SIX SEALED SAMPLES AS PER TP700483 AND NO ISSUES WERE 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. NO ISSUES WERE OBSERVED WITH THE RETURNED SAMPLES THEREFORE NO ROOT CAUSE CAN BE IDENTIFIEDSEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 PEN NDL 32G 6MM 3B TW 70CT JPN WERE UNABLE/DIFFICULT TO PRIME PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; WHEN PRIMING, INSULIN DIDN'T COME OUT AT ALL. THE INSULIN IS NOVO'S RYZODEG. THE CUSTOMER HAS ALREADY ASKED NOVO TO INVESTIGATE THE PEN. AT THE PHARMACY, THE PHARMACIST ATTEMPTED TO OPERATE THE PEN NEEDLE TOGETHER WITH THE PATIENT AND CONFIRMED THAT DRUG DIDN'T COME OUT WITH 2 PEN NEEDLES.

    Additional Manufacturer Narrative · 1

    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 2 PEN NDL 32G 6MM 3B TW 70CT JPN WERE UNABLE/DIFFICULT TO PRIME PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; WHEN PRIMING, INSULIN DIDN'T COME OUT AT ALL. THE INSULIN IS NOVO'S RYZODEG. THE CUSTOMER HAS ALREADY ASKED NOVO TO INVESTIGATE THE PEN. AT THE PHARMACY, THE PHARMACIST ATTEMPTED TO OPERATE THE PEN NEEDLE TOGETHER WITH THE PATIENT AND CONFIRMED THAT DRUG DIDN'T COME OUT WITH 2 PEN NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188078 PEN NDL 32G 6MM 3B TW 70CT JPN PEN NEEDLE FMI BECTON DICKINSON AND CO. 9121516

    Patients

    Seq Age Sex Outcome Treatment
    1