BEUDAMED
    FDA Adverse Event Injury Summary report: N

    21 G X 1.25 IN BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER

    MDR report key: 5470106 · Received March 1, 2016

    Report

    Report Number
    1024879-2016-00009
    Event Type
    Injury
    Date Received
    March 1, 2016
    Date of Event
    February 15, 2016
    Report Date
    March 29, 2016
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    PMA / PMN Number
    K982541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H, DEVICE EVALUATION: RESULT - A SAMPLE WAS RETURNED FOR EVALUATION. THE RETURNED MATERIAL SHOWED THE REPORTED DEFECT. VISUAL INSPECTION OF THE RETURNED CUSTOMER SAMPLE IDENTIFIED NO CAUSE OF THE SAFETY SHIELD DISENGAGEMENT. THERE WAS NO FLASH OR ANY OTHER IDENTIFIABLE DEFECTS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE REPORTED LOT NUMBER 5200527. CONCLUSION - BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE. AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT IS INDETERMINATE. ALL INSPECTIONS MET SPECIFICATION REQUIREMENTS.

    Additional Manufacturer Narrative · 1

    THE MEDICAL DEVICE EXPIRATION DATE IS UNKNOWN AS THE LOT NUMBER IS UNKNOWN. THE DEVICE MANUFACTURE DATE IS UNKNOWN AS THE LOT NUMBER IS UNKNOWN. DEVICE EVALUATION: A SAMPLE HAS BEEN RETURNED FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFETY SHIELD ON THE SUSPECT DEVICE DETACHED EITHER BEFORE OR DURING USE. THE HEALTHCARE PRACTITIONER DID NOT REALIZE THIS, USED THE DEVICE, AND THEN DISPOSED OF IT. ANOTHER MEMBER OF THE MEDICAL STAFF THEN RECEIVED A NEEDLE STICK FROM THE EXPOSED NEEDLE IN THE GARBAGE. SHE HAD ROUTINE POST EXPOSURE LAB WORK BUT THE RESULTS ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128321 21 G X 1.25 IN BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER SAMPLE NEEDLE FMI BECTON, DICKINSON & CO., (BD) 5200527

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention