BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ PEN NEEDLE

    MDR report key: 8383651 · Received March 1, 2019

    Report

    Report Number
    9616656-2019-00199
    Event Type
    Malfunction
    Date Received
    March 1, 2019
    Date of Event
    February 14, 2019
    Report Date
    March 14, 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
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. 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. AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: -UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ PEN NEEDLE WAS "NOT WORKING" AND COULDN'T BE USED TO ADMINISTER "VICTOZA". AS REPORTED BY THE CUSTOMER, " ITEM 320144 LOT 8143599 EXP MAY 2023 USING WITH VICTOZA AND FINDING NEEDLES NOT WORKING. INFORMED OF NON PATIENT END PLACEMENT AND READ CANADA PRIVACY. USING ITEMS FOR 8 YEARS NO OTHER ISSUES. DISCARDED SAMPLES SENDING REPLACEMENT".

    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 THE BD ULTRA-FINE¿ PEN NEEDLE WAS "NOT WORKING" AND COULDN'T BE USED TO ADMINISTER "VICTOZA". AS REPORTED BY THE CUSTOMER, "ITEM 320144 LOT 8143599 EXP MAY 2023 USING WITH VICTOZA AND FINDING NEEDLES NOT WORKING. INFORMED OF NON PATIENT END PLACEMENT AND READ CANADA PRIVACY. USING ITEMS FOR 8 YEARS NO OTHER ISSUES. DISCARDED SAMPLES SENDING REPLACEMENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177327 BD ULTRA-FINE¿ PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. 8143599

    Patients

    Seq Age Sex Outcome Treatment
    1 Other