BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM

    MDR report key: 17080787 · Received June 7, 2023

    Report

    Report Number
    9616656-2023-00553
    Event Type
    Malfunction
    Date Received
    June 7, 2023
    Date of Event
    May 16, 2023
    Report Date
    September 7, 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
    CA, 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: 30-JUN-2023. H6: INVESTIGATION SUMMARY CUSTOMER RETURNED 2 EMPTY SHELF CARTONS, AND 15 LOOSE UNOPENED PEN NEEDLES INSIDE A METAL CANISTER. IT WAS REPORTED BY THE CONSUMER THAT 2 COMPLIMENTARY BOXES OF NANO 2ND GEN PEN NEEDLES WERE RECEIVED. THE CONSUMER STATED THAT THERE WAS NO NEEDLE ON ANY OF THE HUBS. CONSUMER SAID THAT BOTH BOXES ARE NANO 2ND GEN BUT THE HUBS INSIDE HAVE A RED LABEL ON THEM AND DOES NOT HAVE BD WRITTEN ON THE LABELS. ALSO, THE CONSUMER STATED THAT THERE IS NO LOT NUMBER ON THE LABELS. CONSUMER ALSO STATED THAT THE BOXES SAYS THAT IT IS FOR RESEARCH AND DOES NOT CONTAIN NEEDLES. THE RETURNED SAMPLES WERE VISUALLY INSPECTED: 1. ONE SHELF CARTON HAS LOT INFORMATION 2104368. 2. SECOND SHELF CARTON HAS A NOT ¿FOR INVESTIGATION USE ONLY¿. 3. PEN NEEDLES HAVE NO INFORMATION ON THE LABEL AND THE CANULA WAS MISSING. EMBECTA WAS ABLE TO CONFIRM CUSTOMER INDICATED ISSUE. ONE PHOTO OF A 32G X 4MM PEN NEEDLE CARTON AND LOOSE PEN NEEDLES WAS RETURNED FROM AN UNKNOWN LOT NO., CAT. NO. 320550. VISUAL EXAMINATION OF THE RETURNED PHOTO WAS CARRIED OUT AND A PINK TEARDROP LABEL LABELLED EWO ARE PRESENT ON THE PEN NEEDLES. ROOT CAUSE WILL BE DETERMINED AS PART OF CAPA 8408884. CAPA 8408884 WAS RAISED TO ADDRESS THIS ISSUE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM WAS MISSING THE LOT NUMBER WAS MISSING FROM THE LABELS. 2ND OF 2 COMPLAINTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CONSUMER THAT 2 COMPLIMENTARY BOXES OF NANO 2ND GEN PEN NEEDLES WERE RECEIVED. ... THE CONSUMER STATED THAT THERE IS NO LOT NUMBER ON THE LABELS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM WAS MISSING THE LOT NUMBER WAS MISSING FROM THE LABELS. 2ND OF 2 COMPLAINTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CONSUMER THAT 2 COMPLIMENTARY BOXES OF NANO 2ND GEN PEN NEEDLES WERE RECEIVED. THE CONSUMER STATED THAT THERE IS NO LOT NUMBER ON THE LABELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1366922 BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 UNKNOWN 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown