BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ ULTRA-FINE¿ PEN NEEDLES

    MDR report key: 14829814 · Received June 27, 2022

    Report

    Report Number
    8041187-2022-00329
    Event Type
    Malfunction
    Date Received
    June 27, 2022
    Date of Event
    June 3, 2022
    Report Date
    July 13, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY CUSTOMER RETURNED (3) OPEN 32GX4MM BD PEN NEEDLES WITHOUT TEAR DROP LABELS ATTACHED. THE CUSTOMER REPORTED A NEEDLE CLOG DURING PRIMING. THE RETURNED SAMPLES WERE EXAMINED, AND IT WAS OBSERVED THAT ALL 3 PEN NEEDLES FEATURED A BROKEN NON-PATIENT END (NPE) CANNULA. THE BROKEN NPE CANNULAS WOULD PREVENT PROPER FLOW THROUGH THE PEN NEEDLES, HENCE, THE CUSTOMER WOULD THINK THE PEN NEEDLES WERE CLOGGED. SINCE ALL 3 SAMPLES WERE RETURNED AFTER USE, THE PROBABLE CAUSE OF THE BROKEN NPE CANNULAS IS USER ERROR WHEN ATTACHING THE PEN NEEDLES TO A PEN INJECTOR. PEN NEEDLE DHR BATCH 0160115 WAS REVIEWED. THE BATCH NUMBER WAS BUILT WITH PEN NEEDLE ASSEMBLY LINE IN DEC 2020. REVIEW OF THE DHR REVEALED ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. NO QUALITY NOTIFICATION WAS RAISED ON PAST 12 MONTHS ON SIMILAR NON-CONFORMANCE. 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 BROKEN BY THE USER WHEN HANDLING THE PEN NEEDLES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NANO¿ ULTRA-FINE¿ PEN NEEDLES THAT THE NEEDLE CLOGGED DURING PRIMING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED NEEDLE CLOG DURING PRIMING, STATED THAT THERE IS NO INSULIN FLOW.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NANO¿ ULTRA-FINE¿ PEN NEEDLES THAT THE NEEDLE CLOGGED DURING PRIMING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED NEEDLE CLOG DURING PRIMING, STATED THAT THERE IS NO INSULIN FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1939437 BD NANO¿ ULTRA-FINE¿ PEN NEEDLES NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON MEDICAL (SINGAPORE) 0160115

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown