BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM 90 CT MAIL ORDER ONLY

    MDR report key: 8617068 · Received May 16, 2019

    Report

    Report Number
    9616656-2019-00453
    Event Type
    Malfunction
    Date Received
    May 16, 2019
    Date of Event
    May 3, 2019
    Report Date
    May 28, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403897511
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PEN NDL 32G 4MM 90 CT MAIL ORDER ONLY EXPERIENCED CANNULA BREAKAGE, AND AN INABILITY TO DELIVER INSULIN/MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320883, BATCH NO. 7151708. CONSUMER REPORTED WHEN SHE WAS TRYING TO GET HER 22 UNITS OF INSULIN ONLY 5 UNIT CAME. SHE HAD TO USE A NEW PEN NEEDLE FOR THE REST OF THE 17 UNITS. SAMPLE DISCARDED. OCCURENCE-1; INCIDENT DATE-UNKNOWN. CONSUMER REPORTED AFTER SHE THREW THE PEN NEEDLE SHE WENT TO WIPE OFF HER INSULIN PEN FROM AN ALCOHOL SWAB, NEEDLE STICKED HER. SHE REALIZED THAT THE NON PATIENT END NEEDLE WAS REMAINED IN THE PEN. SHE WAS ABLE TO REMOVE THE NEEDLE AND DISPOSED IN THE SHARP CONTAINER.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 NDL 32G 4MM 90 CT MAIL ORDER ONLY EXPERIENCED CANNULA BREAKAGE, AND AN INABILITY TO DELIVER INSULIN/MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320883 BATCH NO. 7151708. VERBATIM: CONSUMER REPORTED WHEN SHE WAS TRYING TO GET HER 22 UNITS OF INSULIN ONLY 5 UNIT CAME. SHE HAD TO USE A NEW PEN NEEDLE FOR THE REST OF THE 17 UNITS. SAMPLE DISCARDED. OCCURRENCE-1; INCIDENT DATE-UNKNOWN. CONSUMER REPORTED AFTER SHE THREW THE PEN NEEDLE SHE WENT TO WIPE OFF HER INSULIN PEN FROM AN ALCOHOL SWAB, NEEDLE STUCK HER. SHE REALIZED THAT THE NON PATIENT END NEEDLE WAS REMAINED IN THE PEN. SHE WAS ABLE TO REMOVE THE NEEDLE AND DISPOSED IN THE SHARP CONTAINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408035 PEN NDL 32G 4MM 90 CT MAIL ORDER ONLY HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 7151708 10885403897511

    Patients

    Seq Age Sex Outcome Treatment
    1 Other