BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO 100 BOX 1200 US

    MDR report key: 20735862 · Received November 20, 2024

    Report

    Report Number
    3023359743-2024-00673
    Event Type
    Malfunction
    Date Received
    November 20, 2024
    Report Date
    January 30, 2025
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K212015
    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 (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. 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

    FROM: [email protected] [email protected]. SENT: SATURDAY, OCTOBER 26, 2024 1:58 PM. TO: PRODUCTCOMPLAINTS <[email protected]. SUBJECT: FW: MALFUNCTIONING OF PEN AND NEEDLE OF INSULIN. PATIENT WENT TO ADMINISTER A NEW INSULIN GLARGINE-YFGN PEN. FIRST TIME USE OF THIS PARTICULAR PEN, ALL OTHERS HAD ADMINISTERED AS NORMAL. PATIENT CLEANED THE GREY RUBBER HUB. EVERYTHING FELT NORMAL AND APPEARED NORMAL. THEN APPLIED THE BD NANO 2ND GEN PEN NEEDLE ON IT. PRIMING IT THE TUBE WITH 2 ML. NOTHING CAME OUT. NORMALLY DROPS OF INSULIN COMES OUT. NEEDLESS TO SAY, UPON READY ADMINISTRATION ABOVE 10 UNITS, THERE WAS RESISTANT. HARD RESISTANCE. UNABLE TO GET ANY INSULIN OUT, DESPITE THE HARD PUSHING OF THE PEN. TOOK THE BD NEEDLE OFF AND HAD NOTICED THE NEEDLE WAS BENT, THERE WAS A SMALL GREY BUMP ON THE GREY RUBBER HUB. PICTURES BEING ATTACHED, AND THE PRODUCT INFORMATION LISTED. INSULIN HAD SOME HOW LEAKED OUT OF THE GREY HUB, PATIENT WAS NOT ABLE TO ADMINISTER NOR DID HE ADMINISTER IT INTO HIS SKIN DUE TO MALFUNCTION OF PRODUCT. 1) INSULIN GLARGINE-YFGN INJECTION 100UNITS/ML (U-100) NDC 83257-015-31 RX ONLY LOT BF 23004724 EXP 2025 OCT BM/0283/02. 2) BD NANO 2ND GEN PEN NEEDLES 4MM X 32G NDC/HRI# 08290-3205-50 320550 BECTON DICKINSON PEN NEEDLE REF (B)(4), LOT 4002182 [(17)290131] ,MFG 2024-02-02 [(11)240202] EXP 2029-01-31 [(10)4002182] D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2460318 PEN NDL 32G 4MM PRO 100 BOX 1200 US NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320550 4002182 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose