BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEN NEEDLE 32X4 LA 5B

    MDR report key: 9678617 · Received February 6, 2020

    Report

    Report Number
    9616656-2020-00093
    Event Type
    Malfunction
    Date Received
    February 6, 2020
    Date of Event
    January 21, 2020
    Report Date
    February 5, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR NEEDLE BENT & MISSING INNER SHIELD ON LOT # 8233917. 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 CONFORMANCE'S WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SAFETY CAP IS MISSING WITH A BD PEN NEEDLE 32X4 LA 5B. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: A QUALITY COMPLAINT IS RECEIVED IN WHICH THE CLIENT STATES THAT: ¿THE GREEN NEEDLES RECEIVED IN THE PREVIOUS ORDER, SOME NEEDLES CAME WITHOUT THE SAFETY CAP.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142924 BD PEN NEEDLE 32X4 LA 5B HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8233917

    Patients

    Seq Age Sex Outcome Treatment
    1 Other