BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO FINE PLUS INSULIN PEN NEEDLE

    MDR report key: 11790499 · Received May 7, 2021

    Report

    Report Number
    9616656-2021-00487
    Event Type
    Malfunction
    Date Received
    May 7, 2021
    Date of Event
    April 8, 2021
    Report Date
    May 21, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY TWO OPEN 32G X 4MM PEN NEEDLE SAMPLES AND FOUR PHOTOS WERE RETURNED FROM LOT. NO. 0162434, CAT. NO. 320136. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLES AND PHOTOS AND A BENT NON PATIENT END OF CANNULA WAS OBSERVED ON THE TWO SAMPLES. DUE TO THE CONDITION THE SAMPLES WERE RETURNED NO CLOG TEST COULD BE CARRIED OUT. 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. AS THE SAMPLES RETURNED WERE OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICRO FINE PLUS¿ INSULIN PEN NEEDLE'S NON-PATIENT END WAS BROKEN AND FAILED TO DELIVER MEDICATION AS A RESULT. THIS OCCURRED 2 TIMES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "DRUG DIDN'T COME OUT. WHEN CHECKING THE PRODUCT, THE NEEDLE NPE WAS FOUND TO BE BROKEN."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD MICRO FINE PLUS¿ INSULIN PEN NEEDLE'S NON-PATIENT END WAS BROKEN AND FAILED TO DELIVER MEDICATION AS A RESULT. THIS OCCURRED 2 TIMES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "DRUG DIDN'T COME OUT. WHEN CHECKING THE PRODUCT, THE NEEDLE NPE WAS FOUND TO BE BROKEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688392 BD MICRO FINE PLUS INSULIN PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 0162434

    Patients

    Seq Age Sex Outcome Treatment
    1