BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17398496 · Received July 26, 2023

    Report

    Report Number
    9616656-2023-00775
    Event Type
    Malfunction
    Date Received
    July 26, 2023
    Date of Event
    July 3, 2023
    Report Date
    September 28, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K182320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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

    H.6. INVESTIGATION SUMMARY: PHOTOS WERE PROVIDED 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 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. CAPA 8408884 WAS RAISED TO ADDRESS THIS ISSUE.

    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 WERE INCORRECT LABEL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT) THERE WERE LABELING ISSUES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FROM PHONE CALL ON(B)(6) 2023 CONSUMER STATED, HE RECEIVED A COMPLIMENTARY BOX FROM US MARKED, "FOR INVESTIGATIONAL USE ONLY" STATED, THE "TEAR DROP LABELS ARE PINK WITH LETTERS THAT READ, EWO" STATED, HE PICKED THE COMPLIMENTARY BOX UP FROM THE PHARMACY IN APRIL AND IS JUST GETTING AROUND TO REPORTING ISSUE. VOICEMAIL: CONSUMER LEFT VOICEMAIL REPORTING THAT HE PICKED UP A COMPLIMENTARY BOX OF NEEDLES THAT WAS SENT TO HIS PHARMACY. HE STATED THAT WHEN HE OPENED THE BOX, HE SAW THAT THE TEAR DROP LABELS WERE PINK AND NONE OF THE HUBS HAD NEEDLES IN THEM.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT) THERE WERE INCORRECT LABEL INFORMATION. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FROM PHONE CALL ON (B)(6) 2023 13:45:32: CONSUMER STATED, HE RECEIVED A COMPLIMENTARY BOX FROM US MARKED, "FOR INVESTIGATIONAL USE ONLY". STATED, THE "TEAR DROP LABELS ARE PINK WITH LETTERS THAT READ, EWO". STATED, HE PICKED THE COMPLIMENTARY BOX UP FROM THE PHARMACY IN APRIL AND IS JUST GETTING AROUND TO REPORTING ISSUE. VOICEMAIL: CONSUMER LEFT VOICEMAIL REPORTING THAT HE PICKED UP A COMPLIMENTARY BOX OF NEEDLES THAT WAS SENT TO HIS PHARMACY. HE STATED THAT WHEN HE OPENED THE BOX, HE SAW THAT THE TEAR DROP LABELS WERE PINK AND NONE OF THE HUBS HAD NEEDLES IN THEM.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT) THERE WERE INCORRECT LABEL INFORMATION. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FROM PHONE CALL ON (B)(6) 2023 13:45:32: CONSUMER STATED, HE RECEIVED A COMPLIMENTARY BOX FROM US MARKED, "FOR INVESTIGATIONAL USE ONLY" STATED, THE "TEAR DROP LABELS ARE PINK WITH LETTERS THAT READ, EWO" STATED, HE PICKED THE COMPLIMENTARY BOX UP FROM THE PHARMACY IN APRIL AND IS JUST GETTING AROUND TO REPORTING ISSUE. VOICEMAIL: CONSUMER LEFT VOICEMAIL REPORTING THAT HE PICKED UP A COMPLIMENTARY BOX OF NEEDLES THAT WAS SENT TO HIS PHARMACY. HE STATED THAT WHEN HE OPENED THE BOX, HE SAW THAT THE TEAR DROP LABELS WERE PINK AND NONE OF THE HUBS HAD NEEDLES IN THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630479 BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT) HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. UNKNOWN 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown