BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOJECT SAFETY NDL 25 X 5/8

    MDR report key: 18126597 · Received November 13, 2023

    Report

    Report Number
    1282497-2023-10807
    Event Type
    Malfunction
    Date Received
    November 13, 2023
    Report Date
    January 25, 2024
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FMI
    UDI-DI
    10884521544710
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS FILED IN ERROR. CARDINAL HEALTH IS NOT THE LEGAL MANUFACTURER OF THIS THIS DEVICE. THE LEGAL MANUFACTURER IS SOL MILLENNIUM MED INC. THE MANUFACTURER HAS BEEN NOTIFIED OF THE EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE RN PULLED UP AN IMMUNIZATION XX INTO A 3 CC SYRINGE USING A BLUNT NEEDLE. AFTERWARD RN REPLACED WITH A HYPODERMIC SAFETY NEEDLE. RN WAS ABLE TO PRIME THE NEEDLE WITHOUT EVENT. RN CLEANSED THE PATIENT'S SKIN WITH AN ALCOHOL SWAB. THIS RN GENTLY SQUEEZED THE SKIN ON THE RIGHT VAS LATERALIS WITH LEFT HAND AND INJECTED NEEDLE AT A 90-DEGREE ANGLE WITH A QUICK THRUST WITH THE RIGHT. RN USED NO MORE FORCE THAN THIS RN TYPICALLY USES FOR IM INJECTION. WHEN INJECTION WAS GIVEN ALL OR MOST OF THE IMMUNIZATION EXPELLED OUT THE SIDE OF THE SYRINGE ALONG THE LUER LOCK OF THE NEEDLE. UPON INSPECTION OF THE NEEDLE AFTER INJECTION, THE NEEDLE WAS SLIGHTLY BENT AND THE HYPODERMIC SAFETY NEEDLE ITSELF LOOKED DAMAGED AT THE LUER LOCK SITE. ADDITIONAL INFORMATION RECEIVED ON 26OCT2023 STATED THAT THEY USED THE NEEDLE WITH A BD PLASTI PAK 3 ML SYRINGE LOT 2181846 . THEY TWISTED THE HUB INTO THE LUER UNTIL IT WOULD NOT TWIST ANYMORE. THE NEEDLE DID NOT APPEAR TO BE BENT PRIOR TO THE INJECTION. THE AREA THAT LOOKED DAMAGED WAS THE HUB WHERE IT ATTACHES TO THE LUER LOCK. IT WAS AS IF THE ENTIRE DEVICE SHIFTED FORWARD STARTING AT A BEND IN THE HUB. THIS WAS NOT NOTICED WHEN THE NEEDLE WAS APPLIED TO THE SYRINGE OR THE NEEDLE WAS BEING PRIMED. THEY DID NOT NOTICE THE NEEDLE WAS BENT UNTIL AFTER THEY HAD APPLIED THE SHIELD SO AT THE TIME THEY WERE NOT SURE IF THIS OCCURRED DURING THE INJECTION OR WHEN THEY APPLIED THE SAFETY SHIELD AS IT IS A HABIT TO AUTOMATICALLY APPLY THE SHIELD WHEN REMOVING THE NEEDLE. THE ENTIRE NEEDLE DEVICE WAS BENT FORWARD IN A WAY THAT THE SAFETY DID NOT COVER THE TIP. THE ENTIRE NEEDLE APPEARED TO BEND FORWARD AWAY FROM THE SAFETY SHIELD AND THE DEFORMITY/BEND IN THE HUB APPEARED TO BE UNDER BELOW THE SAFETY SHIELD ATTACHMENT SITE. THE PATIENT WILL NEED TO RETURN ANOTHER DAY TO MAKE UP THE IMMUNIZATION HOWEVER THERE WAS NOTHING UNUSUAL ABOUT THE INJECTION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1620451 MONOJECT SAFETY NDL 25 X 5/8 NEEDLE, HYPODERMIC, SINGLE LUMEN FMI CARDINAL HEALTH 1182558 02105048 10884521544710

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown