BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER

    MDR report key: 7080392 · Received December 4, 2017

    Report

    Report Number
    1024879-2017-01166
    Event Type
    Malfunction
    Date Received
    December 4, 2017
    Date of Event
    February 14, 2017
    Report Date
    January 3, 2018
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    00382903686070
    PMA / PMN Number
    K982541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION ADDED TO THE FOLLOWING FIELDS: MEDICAL LOT #: 6091894.

    Additional Manufacturer Narrative · 1

    RESULTS - BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR HUB/COLLAR SEPARATION WITH THE INCIDENT LOT WAS OBSERVED. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. CAPA (B)(4) HAS BEEN OPENED FOR THIS DEFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HUB AND COLLAR OF THE BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER WAS DETACHED. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858588 BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER SAMPLE NEEDLE FMI BECTON, DICKINSON & CO., (BD) 6091894 00382903686070

    Patients

    Seq Age Sex Outcome Treatment
    1 Other