BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE NEEDLE

    MDR report key: 10590934 · Received September 26, 2020

    Report

    Report Number
    8041187-2020-00616
    Event Type
    Malfunction
    Date Received
    September 26, 2020
    Date of Event
    September 2, 2020
    Report Date
    September 9, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057581
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION: UNABLE TO CONFIRM THE CUSTOMER EXPERIENCE AS NO PHOTO / SAMPLE IS RECEIVED FOR INVESTIGATION. END USER RISK ASSESSMENT AS PER (B)(4) DOCUMENT, (B)(4), THE SEVERITY FOR SAFETY MECHANISM FAILURE IS SEVERE (S4) OCCURRENCE = (B)(4). THE RISK IS ACCEPTABLE PER (B)(4). ROOT CAUSE DESCRIPTION: NO PHOTO/ SAMPLE WERE RETURNED FOR INVESTIGATION. ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT WILL BE RE-OPENED AND RE-INVESTIGATED IF THE SAMPLE IS RETURNED. RATIONALE: THE COMPLAINT WILL CONTINUED TO BE TRACKED AND MONITORED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ECLIPSE¿ NEEDLES EXPERIENCED SAFETY MECHANISM FAILURE AND A SAFETY MECHANISM THAT WOULD NOT ENGAGE. IT HAS NOT BEEN SPECIFIED WHETHER THE PRODUCT DEFECTS WERE NOTED PRIOR TO, DURING, OR AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305758 BATCH NO. 9081631. COMPLAINT 2 OF 2: THIS RECORD REFLECTS THE #27 NEEDLE. OUR L&D DEPARTMENT HAS HAD MULTIPLE ISSUES WITH THE PRODUCT #'S AND LOT #'S BELOW; WE CANNOT USE THEM. THEY ARE NOT ENGAGING PROPERLY; THEY GET STUCK AT AN ANGLE. OUR RISK MANAGER WILL BE ENTERING THIS INTO MEDSUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055664 BD ECLIPSE NEEDLE NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 305758 9081631 30382903057581

    Patients

    Seq Age Sex Outcome Treatment
    1 Other