BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION PEN NEEDLES 4MM X 32 GAUGE

    MDR report key: 14999433 · Received July 13, 2022

    Report

    Report Number
    3014704491-2022-00271
    Event Type
    Malfunction
    Date Received
    July 13, 2022
    Date of Event
    June 14, 2022
    Report Date
    August 2, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FMI
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES. D9: RETURNED TO MANUFACTURER ON: 18-AUG-2022. H6: INVESTIGATION SUMMARY CUSTOMER RETURNED A TOTAL OF 20 USED AND 10 UNUSED 4MM, 32 GAUGE NANO PEN NEEDLES FROM LOT 1033298. THE PEN NEEDLES WERE VISUALLY INSPECTED PRIOR TO TESTING. 15 OF THE USED PEN NEEDLES WERE FOUND TO HAVE BENT NEEDLES ON THE NON-PATIENT SIDE OF THE HUB¿S NEEDLE CANNULA. THIS DAMAGE WOULD PREVENT TESTING FOR CLOGS SINCE THE NEEDLE CANNOT PROPERLY ATTACH TO THE PEN. AS A RESULT, THE PEN NEEDLES APPEAR TO BE CLOGGED DURING USE. BASED ON THE DAMAGE PRESENT, THE NEEDLES BENDING MAY HAVE OCCURRED ACCIDENTALLY WHILE THE USER WAS PREPARING THE PEN NEEDLE FOR USE, POTENTIALLY IF THE PEN WAS NOT PROPERLY ALIGNED WITH THE CANNULA. THE REMAINING UNUSED AND UNDAMAGED SAMPLES WERE ATTACHED TO A TEST PEN FILLED WITH SALINE. SALINE WAS PUSHED THROUGH THE SYSTEM AND OUT THE DISTAL TIP OF THE REMAINING PEN NEEDLES. NO ISSUES WERE FOUND WITH THE REMAINING PEN NEEDLES, REGARDLESS OF PRIOR USE. DHR WAS REVIEWED AND THERE WERE NOT ANY QNS OR OTHER EVENTS THAT COULD BE RELATED TO THIS COMPLAINT. BASED ON THE SAMPLES RECEIVED, EMBECTA FOUND THAT 15 USED PEN NEEDLES HAD BECOME BENT ON THE NON-PATIENT SIDE. THIS DAMAGE COULD RESEMBLE THE NEEDLE BEING CLOGGED AS A RESULT OF INSULIN NOT PASSING THROUGH THE NEEDLE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING RELION PEN NEEDLES 4MM X 32 GAUGE THAT WHEN PRIMING NO INSULIN FLOWS ON 18 PEN NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED WHEN PRIMING NO INSULIN FLOWS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING RELION PEN NEEDLES 4MM X 32 GAUGE THAT WHEN PRIMING NO INSULIN FLOWS ON 18 PEN NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED WHEN PRIMING NO INSULIN FLOWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1669991 RELION PEN NEEDLES 4MM X 32 GAUGE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1033298

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown