BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 32G 4MM 5B XTW 100CT EU

    MDR report key: 21906076 · Received April 24, 2025

    Report

    Report Number
    3023359743-2025-00306
    Event Type
    Malfunction
    Date Received
    April 24, 2025
    Report Date
    May 15, 2025
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO: B4, G6, H2, H3, H11. CORRECTION TO: H6 (COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS) INVESTIGATION SUMMARY: NO PHYSICAL SAMPLES WERE RECEIVED HOWEVER THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTO(S) PROVIDED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED, AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. NO DEFINITIVE ROOT CAUSE DETERMINED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATION ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    HI ALL, I RECEIVED A CALL FROM A PATIENT WHO HAD SOME FAULTY NEEDLES AND SHE ASKED TO GET REPLACEMENTS. THE DETAILS OF THE NEEDLES ARE: - ITEM: 320584, LOT: 4142029. SHE SAID THERE WAS ROUGHLY 15 UNITS THAT WERE FAULTY, EXPLAINING THE THEY WERE FOLDED OVER AND THAT THE INSULIN WAS ABLE TO COME OUT AND THAT THE NEEDLE WAS COMING OUT INTO THE SPONGY BIT. THE PATIENT IS ELDERLY AND HARD OF HEARING AND SIGHT. PLEASE CAN SOMEONE CONTACT HER BACK TO DISCUSS (B)(6) 07APRIL2025. ADDITIONAL ISSUES - (CAPTURED IN COMP-(B)(4): CLOG, COMP - (B)(4): DIMENSION/SHORT, COMP-(B)(4): MISSING CANNULA NPE). IN CASE BD.UK DID NOT PROVIDE DETAILS FORWARD DETAILS ALL BUT ONE OF THE 11 & THE 4 CAME FROM THE BOX REF: 320584, LOT: 4142029. ONE FAULTY ONE CAME FROM AN EARLIER BOX WHICH L DO NOT HAVE ANY DETAILS. PHOTO 1: THE 4 ABOVE. THERE ARE 2 PROBLEMS WHICH ARE HARDER TO SEE FAULTY: ONLY WHEN APPLY ¿NORMAL TEST 2UNIT SPRAY¿ - BEFORE LOADING PEN OF UNITS REQUIRED FOR USE. HOWEVER FAULTY DO NOT PRODUCE NECESSARY 1ST SPRAY. 1. THE USUAL NEEDLE OF A FAULTY ONE IS FAR TOO SHORT FOR PIERCING THE SPONGE ON THE INSULIN PEN TO INJECT. 2. THERE IS NO NEEDLE UNDERNEATH AT ALL SO V HARD GET A PHOTO AS MOSTLY WHITE. SOMETIMES IN CENTRE BLACK CIRCLE & INSIDE IT TINY SILVER BLOB. UNDERNEATH THE 4 THERE ARE 11 WHICH HAVE MOST COMMON FAULT THOUGH NOT ALWAYS THE SAME! USUAL NEEDLE IS FLAT SO CAN SEE EASILY FAULTY - BUT SOME FLAT ARE NOT AS LONG WHEN FOLDED OVER. A FIRST FOR ME SEVERAL THIS TIME HAVE A HIGH LOOP UP IN THE AIR & THEN BEND OVER SO SHORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484300 PEN NEEDLE 32G 4MM 5B XTW 100CT EU NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320584 4142029

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female