BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE AUTOSHIELD DUO 30GX5MM USA

    MDR report key: 20665259 · Received November 12, 2024

    Report

    Report Number
    3023359743-2024-00657
    Event Type
    Malfunction
    Date Received
    November 12, 2024
    Report Date
    November 12, 2024
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    UDI-DI
    00382903295159
    PMA / PMN Number
    K223286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 2ND 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. 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 SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    MATERIAL # 329515. MATERIAL DESCRIPTION - PEN NEEDLE AUTOSHIELD DUO 30GX5MM USA. MATERIAL LOT# - 4032897. COMPLAINT DESCRIPTION: WE ARE HAVING SOME ISSUES WITH MFG#329515 LOT#4032897. I HAVE TWO PATIENT SAFETY REPORTS FOR THIS PRODUCT. PLEASE SEE DETAILS BELOW. WE ARE TRYING TO DETERMINE WHAT THE BEST COURSE OF ACTION IS FOR STAFF MOVING FORWARD. THANKS, (B)(4). THE PATIENT HAD 40 UNITS OF LONG ACTING INSULIN DUE. RN PROCEEDED TO ATTACH A AUTOSHIELD DUO NEEDLE TO THE HUB OF THE RESVOGLAR KWIKPEN. RN PRIMED THE NEEDLE WITH 2 UNITS AND THEN TURNED THE DIAL TO 40 AND DOUBLE SIGNED WITH ANOTHER RN. PRIMARY RN PROCEEDED TO GIVE THE RESVOGLAR KWIKPEN AND WHEN INJECTING THE PATIENT, THE NEEDLE PIERCED THE SKIN AND THE DIAL WAS PUSHED TO 20 UNITS WHEN IT WOULD NOT PUSH ANY FURTHER. PRIMARY RN REPEATED THE STEPS OF PRIMING ANOTHER NEEDLE TO GIVE REMAINING 20 UNITS OF INSULIN BUT STILL WOULD NOT ADMINISTER. WHEN TAKING OFF THE SECOND NEEDLE, THE RN WAS SPRAYED WITH INSULIN DUE TO PRESSURE BUILD-UP IN THE INSULIN CHAMBER. CHARGE RN AND PHARMACIST WAS NOTIFIED AND REMAINING 20 UNITS OF RESVOGLAR INSULIN WAS GIVEN USING A NEW RESVOGLAR KWIKPEN. NO IMAGES WERE PROVIDED BY CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1136052 PEN NEEDLE AUTOSHIELD DUO 30GX5MM USA Needle, hypodermic, single lumen FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 329515 4032897 00382903295159

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose