BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SHARPS COLLECTOR 9 GAL

    MDR report key: 8255862 · Received January 17, 2019

    Report

    Report Number
    2243072-2018-01987
    Event Type
    Malfunction
    Date Received
    January 17, 2019
    Date of Event
    December 28, 2018
    Report Date
    March 5, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    50382903056168
    PMA / PMN Number
    K943134
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THE DHR REVIEW PROCESS WAS NOT PERFORMED DUE TO THE LOT NUMBER WAS UNKNOWN. BASED ON THE PICTURES PROVIDED FROM CUSTOMER IT CAN CONFIRMED THIS ISSUE LIKE A FAILURE MODE GENERATED IN THE MANUFACTURING PROCESS. DURING THIS INVESTIGATION IT WAS NOTED THAT AN IMPROVEMENT ACTION WAS ALREADY IMPLEMENTED IN THE MANUFACTURING PROCESS. HOWEVER, ADDITIONAL INFORMATION LIKE A LOT NUMBER OR PICTURE FROM THE ORIGINAL PACKAGING IS NEEDED TO CONFIRM IF THIS ISSUE CAME UP BEFORE OR AFTER THE IMPROVEMENT ACTION. POTENTIAL ROOT CAUSE NON-CONTROLLED METHOD TO SHIP PARTIAL BOXES TO END USER. INCORRECT HANDLING/STORAGE. PRODUCT MANUFACTURED BEFORE OF CAPA IMPLEMENTATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 7 BD¿ SHARPS COLLECTOR 9 GAL CONTAINERS WERE MISSING AND LIDS WERE MISSING SLIDE PART.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS FLEXTRONICS. THIS SITE IS AN OEM MANUFACTURING SITE. (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 7 BD¿ SHARPS COLLECTOR 9 GAL CONTAINERS WERE MISSING AND LIDS WERE MISSING SLIDE PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49651 BD¿ SHARPS COLLECTOR 9 GAL HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON UNKNOWN 50382903056168

    Patients

    Seq Age Sex Outcome Treatment
    1 Other