BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO 100 BOX 1200 CA

    MDR report key: 21911046 · Received April 25, 2025

    Report

    Report Number
    3023359743-2025-00310
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Report Date
    May 15, 2025
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    Adverse Event
    Yes
    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, B5, G6, H2, H3, H11. CORRECTION TO: E1 (COUNTRY TYPE), H6 (HEALTH EFFECT - CLINICAL 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

    ADULT CHILD OF CONSUMER REPORTED BY EMAIL FATHER HAVING ELEVATED GLUCOSE VALUES GETTING 9-11 MOL SINCE SWITCHING TO THE BD BRAND OF NEEDLES. LOT#: UNKNOWN, CATALOG#: UNKNOWN - BD NANO PRO 100CT, 4MM, DATE OF EVENT: UNKNOWN - PAST SEVERAL DAYS, SAMPLE STATUS: NO. TWO OUTBOUND EMAIL ATTEMPTS MADE TO OBTAIN MORE INFORMATION FROM THIS CONSUMER (B)(6). CUSTOMER SUPPORT: ON (B)(6) 10:10 AM, BD-CANADA CUSTOMER <[email protected]>. CONSUMER SENT TO BD SENT: ON (B)(6) 2025 6:58 AM. TO: [email protected]. SUBJECT: BD NANO PRO 4MM NEEDLES HELP. DEAR BD, WE RECENTLY PURCHASED A 100 BOX OF YOUR NANO PRO 4MM NEEDLES FOR MY FATHER. WE'VE NOTICED IN THE PAST SEVERAL DAYS SINCE SWITCHING NEEDLES (HE WAS PREVIOUSLY USING A DIFFERENT BRAND BUT SAME 32G 4MM SIZE) HIS NUMBERS ARE CONSISTENTLY HIGHER IN THE MORNING AFTER TAKING INSULIN THE PREVIOUS MORNING. BEFORE HE WOULD GET 6-7 - MOL BUT HE'S BEEN GETTING 9-11 MOL SINCE SWITCHING TO THE BD BRAND OF NEEDLES. WE BELIEVE THIS CHANGE IS A RESULT OF THE CHANGE OF NEEDLES. IS IT POSSIBLE TO GET A REFUND FOR THESE NEEDLES FOR THE REMAINING QTY SO THAT WE CAN RE-PURCHASE OUR PREVIOUS BRAND? WE'VE ONLY USED SEVERAL NEEDLES OUT OF 100, AND THEY WERE NOT CHEAP. UNFORTUNATELY, THE PHARMACY WILL NOT TAKE THESE BACK. VCOYNE 04APRIL2025, UPDATE TO CASE#: (B)(4) FROM CUSTOMER CARE. CONSUMER EMAILED 04.02.2025, ITEM#: 320555, LOT#: 4163063. PHOTO OF FINGER. PHOTO OF NEEDLE ON THE PEN WITH THE NEEDLE POKING THRU INNER SHIELD. CONSUMER ADULT CHILD REPORTED GETTING INCREASED GLUCOSE VALUES WITH USE OF NANO PRO PEN NEEDLE#: 320555. CONSUMER ADULT CHILD REPORTED GETTING NEEDLE CLOG DURING FLOW CHECK. CONSUMER ADULT CHILD REPORTED - WHILE RESHIELDING THE NEEDLE AFTER ADMINISTERING INSULIN, THE NEEDLE POKED THRU THE GREEN SHIELD AND STUCK HIS FINGER. NO MEDICAL ATTENTION RECEIVED FROM THIS INCIDENT AS OF DATE. BUT LEFT A BUMP ON THE SITE. LOT#: 4163063, CATALOG#: 320555, DATE OF EVENT UNKNOWN, SAMPLE STATUS: NOT AWAITING SAMPLES.

    Description of Event or Problem · 0

    UPDATE/ADDITIONAL INFORMATION FROM CUSTOMER CARE - SEE ATTACHMENTS. CONSUMER CALLED TO INFORM OF HIS ADDRESS FOR REPLACEMENT BOX. DISCARDED THE SAMPLE. CONSUMER INFORMED AFTER INJECTING HIS FATHER, HE PLACED THE INNER SHIELD OVER THE USED NEEDLE. THE NEEDLE WENT THRU THE INNER SHIELD AND STUCK HIS FINGER. NO MEDICAL ATTENTION WAS RECEIVED FROM THIS INCIDENT. JUST A LITTLE SWELLING THAT SUBSIDED THE NEXT DAY. -ALSO, FROM THIS BOX HAD PEN NEEDLES THAT CLOGGED DURING THE FLOW CHECK. INFORMED CALLER OF PROPER PLACEMENT OF NON-PATIENT END. ITEM # 320555. LOT # 4163063. PHOTOS ATTACHED OF BOX. PHOTO OF FINGER. PHOTO OF NEEDLE ON THE PEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389338 PEN NDL 32G 4MM PRO 100 BOX 1200 CA NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 000000000000320555 4163063

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown