BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ NEEDLE

    MDR report key: 9535288 · Received December 31, 2019

    Report

    Report Number
    8041187-2019-01051
    Event Type
    Malfunction
    Date Received
    December 31, 2019
    Date of Event
    November 5, 2019
    Report Date
    December 16, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057611
    PMA / PMN Number
    K161170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE REPORTED DEFECT CANNOT BE CONFIRMED AS ACTUAL SAMPLE WAS NOT RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT WILL BE RE-OPENED AND RE-INVESTIGATED IF THE SAMPLE IS RETURNED. INVESTIGATION CONCLUSION: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF SAFETY SHIELD BROKE OFF WITH LOT #8241495 REGARDING ITEM #305761. ROOT CAUSE DESCRIPTION: HE REPORTED DEFECT CANNOT BE CONFIRMED AS ACTUAL SAMPLE WAS NOT RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT WILL BE RE-OPENED AND RE-INVESTIGATED IF THE SAMPLE IS RETURNED. RATIONALE: UNABLE TO CONFIRM THE CUSTOMER EXPERIENCE AS ACTUAL SAMPLE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFETY MECHANISM DETACHED DURING USE WITH A BD ECLIPSE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE NEEDLE AND SAFETY DEVICE DETACHED FROM THE NEEDLE WHEN THE MA ATTEMPTED TO CLOSE THE SAFETY DEVICE. NO INJURY TO PT OR EMPLOYEE. NEEDLE ATTACHED TO FLU VACCINE DISCARDED INTO SHARP BIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331769 BD ECLIPSE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 8241495 30382903057611

    Patients

    Seq Age Sex Outcome Treatment
    1 Other