BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO FINE PLUS INSULIN PEN NEEDLE

    MDR report key: 8859996 · Received August 5, 2019

    Report

    Report Number
    9616656-2019-00704
    Event Type
    Malfunction
    Date Received
    August 5, 2019
    Date of Event
    July 19, 2019
    Report Date
    August 30, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: FOUR PHOTOS OF A 32G X 4MM PEN NEEDLE SAMPLE WERE RETURNED FROM LOT NO: 9022895, CAT NO: 320136. VISUAL EXAMINATION OF THE RETURNED PHOTOS WAS CARRIED OUT AND A BROKEN NON PATIENT END OF CANNULA 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 PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. BASED ON THE PHOTO RETURNED AND THE FACT NO SAMPLE WAS RETURNED FOR ANALYSIS IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED. H3 OTHER TEXT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MEDICATION WOULDN'T FLOW PROPERLY FROM THE BD MICRO FINE PLUS¿ INSULIN PEN NEEDLE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "DRUG DIDN'T COME OUT PROPERLY."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICATION WOULDN'T FLOW PROPERLY FROM THE BD MICRO FINE PLUS¿ INSULIN PEN NEEDLE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "DRUG DIDN'T COME OUT PROPERLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656860 BD MICRO FINE PLUS INSULIN PEN NEEDLE PISTON SYRINGE FMF BECTON DICKINSON AND CO. 9022895

    Patients

    Seq Age Sex Outcome Treatment
    1 Other