BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLES

    MDR report key: 15506062 · Received September 29, 2022

    Report

    Report Number
    9616656-2022-01059
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    September 6, 2022
    Report Date
    November 17, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K212015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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: 30-SEP-2022. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (19) OPEN 32GX4MM BD PEN NEEDLES WITHOUT TEAR DROP LABELS ATTACHED. THE CUSTOMER REPORTED THAT THE FLOW CHECK FAILS, AND THE NON-PATIENT END (NPE) NEEDLE IS MISSING. THE SAMPLES WERE EXAMINED, AND IT WAS OBSERVED THAT 3 PEN NEEDLES FEATURED A BROKEN NPE CANNULA, AND 16 PEN NEEDLES FEATURED A BENT NPE CANNULA. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. THE BENT AND BROKEN NPE CANNULAS WOULD PREVENT PROPER FLOW THROUGH THE PEN NEEDLES, HENCE, THE CUSTOMER WOULD THINK THE PEN NEEDLES WERE CLOGGED OR THAT THE NPE CANNULA WAS MISSING. SINCE ALL 19 SAMPLES WERE RETURNED AFTER USE, THE PROBABLE CAUSE OF THE BENT AND BROKEN NPE CANNULAS IS USER ERROR WHEN ATTACHING THE PEN NEEDLES TO A PEN INJECTOR. NO DHR REVIEW CAN BE CARRIED OUT AS LOT NUMBER IS UNKNOWN. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. THE ROOT CAUSE FOR THIS ISSUE IS USER RELATED. THE NPE CANNULAS WERE BENT AND BROKEN AFTER THE USER HANDLED THE PEN NEEDLES.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 16 BD NANO¿ 2ND GEN PEN NEEDLES FLOW CHECK FAILED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FIRST NOTICED FLOW CHECK FAILS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 16 BD NANO¿ 2ND GEN PEN NEEDLES FLOW CHECK FAILED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FIRST NOTICED FLOW CHECK FAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2930241 BD NANO¿ 2ND GEN PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 UNKNOWN 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown