BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT)

    MDR report key: 17423857 · Received July 31, 2023

    Report

    Report Number
    9616656-2023-00797
    Event Type
    Malfunction
    Date Received
    July 31, 2023
    Date of Event
    May 10, 2023
    Report Date
    September 28, 2023
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K182320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 06-JUL-2023. H6: INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. 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

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D.4 DEVICE EXPIRATION DATE: UNKNOWN H3. 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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT) HAD INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHARMACIST STATED, THE COMPONENTS WERE IN THE BOX BUT NEEDLES WERE MISSING, PATIENT AND NON PATIENT END.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT) HAD INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHARMACIST STATED, THE COMPONENTS WERE IN THE BOX BUT NEEDLES WERE MISSING, PATIENT AND NON PATIENT END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1660715 BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT) HYPODERMIC SINGLE LUMEN NEEDLE FMI BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. UNKNOWN 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown