BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO FINE PLUS¿ INSULIN PEN NEEDLE

    MDR report key: 8874296 · Received August 8, 2019

    Report

    Report Number
    9616656-2019-00722
    Event Type
    Malfunction
    Date Received
    August 8, 2019
    Date of Event
    July 22, 2019
    Report Date
    September 5, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    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: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. THIRTEEN OPEN 32G X 4MM PEN NEEDLE SAMPLES AND SEVEN PHOTOS WERE RETURNED FROM LOT. NO¿S. 7236653, 8100760, 8072971, 8100759 AND 8227636. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLES AND THE FOLLOWING WAS OBSERVED: LOT. NO. 7236653 A BROKEN NON PATIENT END OF CANNULA WAS OBSERVED ON ONE SAMPLE AND A BENT NON PATIENT END OF CANNULA WAS OBSERVED ON TWO SAMPLES. LOT. NO. 8100760 A BENT NON PATIENT END OF CANNULA WAS OBSERVED ON ALL FOUR SAMPLES. LOT. NO. 8072971 A BENT NON PATIENT END OF CANNULA WAS OBSERVED ON TWO SAMPLES. LOT. NO. 8100759 A BENT NON PATIENT END OF CANNULA WAS OBSERVED ON TWO SAMPLES AND A BROKEN NON PATIENT END OF CANNULA WAS OBSERVED ON ONE SAMPLE. LOT. NO. 8227636 A BENT NON PATIENT END OF CANNULA WAS OBSERVED ON ONE SAMPLE. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE HENCE THE ROOT CAUSE IS UNDETERMINED. AS ALL SAMPLES RETURNED WERE OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD MICRO FINE PLUS¿ INSULIN PEN NEEDLE HAS BEEN FOUND EXPERIENCING 13 OCCURRENCES OF DIFFICULTY FUNCTIONING DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: CUSTOMER COULDN'T ATTACHED THE PEN NEEDLE TO THE PEN.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 7236653. MEDICAL DEVICE EXPIRATION DATE: 2022-08-31. DEVICE MANUFACTURE DATE: 2017-08-24. MEDICAL DEVICE LOT #: 8100760. MEDICAL DEVICE EXPIRATION DATE: 2023-04-30. DEVICE MANUFACTURE DATE: 2018-04-10. MEDICAL DEVICE LOT #: 8072971. MEDICAL DEVICE EXPIRATION DATE: 2023-03-31. DEVICE MANUFACTURE DATE: 2018-03-13. MEDICAL DEVICE LOT #: 8100759. MEDICAL DEVICE EXPIRATION DATE: 2023-04-30. DEVICE MANUFACTURE DATE: 2018-04-10. MEDICAL DEVICE LOT #: 8227636. MEDICAL DEVICE EXPIRATION DATE: 2023-08-31. DEVICE MANUFACTURE DATE: 2018-08-15. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE BD MICRO FINE PLUS¿ INSULIN PEN NEEDLE HAS BEEN FOUND EXPERIENCING 13 OCCURRENCES OF DIFFICULTY FUNCTIONING DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: CUSTOMER COULDN'T ATTACHED THE PEN NEEDLE TO THE PEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669425 BD MICRO FINE PLUS¿ INSULIN PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other