BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLES

    MDR report key: 17222316 · Received June 28, 2023

    Report

    Report Number
    9616656-2023-00667
    Event Type
    Malfunction
    Date Received
    June 28, 2023
    Date of Event
    June 8, 2023
    Report Date
    September 28, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K212015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 28-SEP-2023. SAMPLES RECEIVED. THE EMBECTA CUSTOMER SERVICE TEAM CONNECTED WITH THE BD FULFILLMENT CENTER IN FRANKLIN LAKES, NJ. CONFIRMATION WAS PROVIDED ON (B)(6) 2023 THAT THE BD FULFILLMENT CENTER PROVIDED THE EWO PRODUCT TO SAVON DRUGS (THE PHARMACY FILING THE COMPLAINT). THIS WAS THE ONLY COMPLAINT IN WHICH IT WAS CONFIRMED THAT THE BD FULFILLMENT CENTER WAS RESPONSIBLE FOR DISTRIBUTION OF THE EWO PRODUCT, BUT GIVEN THAT ALL COMPLAINT RECORDS CITE BEING ¿REIMBURSEMENT¿ OR ¿REPLACEMENT¿ PRODUCT, IT CAN BE CONCLUDED THAT ALL COMPLAINTS WERE DERIVED FROM SHIPMENTS MADE OUT OF US FULFILLMENT. NO DHR REVIEW CAN BE CARRIED OUT AS LOT NUMBER IS UNKNOWN. THE FOLLOWING ROOT CAUSES WERE IDENTIFIED FOR THE INVESTIGATED ISSUE BASED ON THE COMPLETED ROOT CAUSE ANALYSIS: USE OF COMMERCIAL SHELF CARTONS FOR PACKAGING OF EWO PRODUCTS. IMPROPER FULFILMENT PRODUCT RECEIVING PROCESS THAT ALLOWED NON-COMMERCIAL EWO PRODUCTS TO GET INTO SECURED FULFILLMENT INVENTORY UNHINDERED. LACK OF DETAILED EWO LABELING REQUIREMENTS IN GLOBAL EWO PROCEDURES CP50015, CP50058, AND LOCAL DL EWO PROCEDURE Q-SOP-225-DL TO ENSURE THAT EWO PRODUCT LABELING PROVIDES CLEAR DIFFERENTIATIONS FROM COMMERCIAL PRODUCTS ON ALL PRODUCT PACKAGING / LABELING LEVELS UNLESS COMMERCIAL PACKAGING AND / OR LABELING COMPONENTS ARE REQUIRED FOR THE INTENDED USE OF EWO PRODUCTS. LACK OF REQUIREMENTS IN FULFILMENT PROCESS PROCEDURE CS-045 FOR VERIFICATION OF PRODUCT INFORMATION ON THE DEVICES SELECTED FOR FULFILMENT. A CAPA WAS RAISED TO ADDRESS THIS ISSUE. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B5. IT WAS REPORTED WHILE USING BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT) THERE WAS INCORRECT LABEL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH AN UNSPECIFIED AMOUNT OF BD NANO¿ 2ND GEN PEN NEEDLES THE BOX IS LABELED "FOR INVESTIGATION USE ONLY." THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER RECEIVED A BOX OF NANO 2ND PEN NEEDLES AND REPORTED THAT THE TEAR DROP LABELS ON THE NEEDLES ARE PINK, AND THE BOX STATES "FOR INVESTIGATION USE ONLY."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH AN UNSPECIFIED AMOUNT OF BD NANO¿ 2ND GEN PEN NEEDLES THE BOX IS LABELED "FOR INVESTIGATION USE ONLY.". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER RECEIVED A BOX OF NANO 2ND PEN NEEDLES AND REPORTED THAT THE TEAR DROP LABELS ON THE NEEDLES ARE PINK, AND THE BOX STATES "FOR INVESTIGATION USE ONLY.".

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT) THERE WAS INCORRECT LABEL INFORMATION. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER RECEIVED A BOX OF NANO 2ND PEN NEEDLES AND REPORTED THAT THE TEAR DROP LABELS ON THE NEEDLES ARE PINK, AND THE BOX STATES "FOR INVESTIGATION USE ONLY." THE CONSUMER STATED THAT THERE IS NO PATIENT END OR NON PATIENT END NEEDLE. HE STATED THAT ALL OF THE NEEDLES IN THE BOX ARE THE SAME. CONSUMER WAS NOT ABLE TO LOCATE A LOT NUMBER ON THE BOX, HE SAID THERE IS NO LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308535 BD NANO¿ 2ND GEN PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 UNKNOWN 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown