BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLE

    MDR report key: 16624161 · Received March 27, 2023

    Report

    Report Number
    9616656-2023-00283
    Event Type
    Malfunction
    Date Received
    March 27, 2023
    Date of Event
    March 8, 2023
    Report Date
    July 13, 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
    PA, US
    Reporter Occupation
    003

    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: 22-MAR-2023. H6: INVESTIGATION SUMMARY CUSTOMER RETURNED A TOTAL OF (24) 32GA 4MM PRO OPEN PEN NEEDLES. 6 FROM THE LOT# 2180165 AND 18 FROM THE LOT#2165548. ALL THE TEAR DROP LABEL ARE HALF OPENED. IT WAS REPORTED THAT FINDING THE PEN NEEDLES TO CLOG. FOR LOT# 2180165: RETURNED PEN NEEDLES VISUALLY EXAMINED AND OBSERVED TWO BROKEN NPE CANNULA, THREE BENT NPE CANNULAS AND ONE WITHOUT ANY DAMAGES. CLOG TEST WAS PERFORMED AND OBSERVED NO ISSUES FOR THE ONE WITHOUT ANY DAMAGE. MOST LIKELY THE CUSTOMER COMPLAINT NEEDLE CLOG OCCURRED DUE TO BENT/BROKEN NPE CANNULA. AS THE SAMPLES RETURN WERE OPEN, ROOT CAUSE CANNOT BE DETERMINED. EMBECTA WAS ABLE TO CONFIRM THE ISSUE AS BENT/BROKEN NPE. FOR LOT# 2165548: RETURNED PEN NEEDLES VISUALLY EXAMINED AND OBSERVED SIX BROKEN NPE CANNULA, EIGHT BENT NPE CANNULAS AND FOUR WITHOUT ANY DAMAGES. CLOG TEST WAS PERFORMED AND OBSERVED NO ISSUES FOR THE ONES WITHOUT ANY DAMAGES. MOST LIKELY THE CUSTOMER COMPLAINT NEEDLE CLOG OCCURRED DUE TO BENT/BROKEN NPE CANNULA. AS THE SAMPLES RETURN WERE OPEN, ROOT CAUSE CANNOT BE DETERMINED. EMBECTA WAS ABLE TO CONFIRM THE ISSUE AS BENT/BROKEN NPE. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. BASED ON THE SAMPLE RECEIVED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER INDICATED ISSUE AS BENT/BROKEN NPE. ROOT CAUSE CANNOT BE DETERMINED AS THE RETURN SAMPLES WERE OPEN. H3

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2165548, MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2027, DEVICE MANUFACTURE DATE: 14-JUN-2022. MEDICAL DEVICE LOT #: 2180165, MEDICAL DEVICE EXPIRATION DATE: 31-JUN-2027, DEVICE MANUFACTURE DATE: 29-JUN-2022. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 14 BD NANO¿ 2ND GEN PEN NEEDLES FROM LOT 2165548, AND 7 NEEDLES FROM LOT 2180165 CLOGGED DURING THE PRIMING PROCESS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED FINDING THE PEN NEEDLES TO CLOG - DURING THE FLOW CHECK ON MOST ALL SAMPLES."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 14 BD NANO¿ 2ND GEN PEN NEEDLES FROM LOT 2165548, AND 7 NEEDLES FROM LOT 2180165 CLOGGED DURING THE PRIMING PROCESS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED FINDING THE PEN NEEDLES TO CLOG - DURING THE FLOW CHECK ON MOST ALL SAMPLES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426843 BD NANO¿ 2ND GEN PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 SEE H10 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown