BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ULTRA-FINE¿ MICRO PEN NEEDLES

    MDR report key: 15305832 · Received August 26, 2022

    Report

    Report Number
    9616656-2022-00910
    Event Type
    Injury
    Date Received
    August 26, 2022
    Date of Event
    August 2, 2022
    Report Date
    August 4, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903207497
    PMA / PMN Number
    K213478
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: A COMPLAINT LOT HISTORY CHECK WAS PERFORMED ON LOT # 1334600 FOR NEEDLE STICK NPE. THIS IS THE 1ST. RELATED COMPLAINT FOR NEEDLE STICK NPE ON LOT # 1334600. NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: EMBECTA WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. 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

    IT WAS REPORTED THAT THERE WAS A DIRTY NEEDLE STICK OF THE BD ULTRA-FINE¿ MICRO PEN NEEDLE AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE DAUGHTER SCRAPED HER FINGER WITH THE NON-PATIENT END NEEDLE WHEN REMOVED FROM PEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2200887 BD ULTRA-FINE¿ MICRO PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 1334600 00382903207497

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other