BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G

    MDR report key: 17446899 · Received August 2, 2023

    Report

    Report Number
    9616656-2023-00820
    Event Type
    Malfunction
    Date Received
    August 2, 2023
    Date of Event
    July 14, 2023
    Report Date
    September 7, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403928659
    PMA / PMN Number
    K213478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES, D.9. RETURNED TO MANUFACTURER ON: 08-SEP-2023. H.6. INVESTIGATION SUMMARY: SAMPLES RECEIVED AND AN INVESTIGATION WAS PERFORMED. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. 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 (B)(4) AND LOCAL DL EWO PROCEDURE (B)(4) 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. CAPA 8408884 WAS RAISED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G THE LABEL HAD INCORRECT INFORMATION. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT SHE RECEIVED A DEMO BOX OF NANO PEN NEEDLES. SHE STATED THAT THE BOX HAS EWO WRITTEN ON IT AND THE TEAR DROP LABELS ARE PINK AND THERE ARE NO NEEDLES ATTACHED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G THE LABEL HAD INCORRECT INFORMATION. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT SHE RECEIVED A DEMO BOX OF NANO PEN NEEDLES. SHE STATED THAT THE BOX HAS EWO WRITTEN ON IT AND THE TEAR DROP LABELS ARE PINK AND THERE ARE NO NEEDLES ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325714 BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. UNKNOWN 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown