BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SHARPS COLLECTOR

    MDR report key: 8155261 · Received December 12, 2018

    Report

    Report Number
    2243072-2018-01788
    Event Type
    Malfunction
    Date Received
    December 12, 2018
    Date of Event
    November 27, 2018
    Report Date
    January 17, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    10885403960109
    PMA / PMN Number
    K943139
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) BD 1.4 QT HOME SHARPS CONTAINER. CUSTOMER STATES THAT THE LOT NUMBER ON THE CONTAINERS DIFFERS FROM THE LOT # ON THE BOXES. THE RETURNED SAMPLE WAS EXAMINED AND EXHIBITED LOT # 8130001 PRINTED ON THE SHELF CARTON AND LOT # 8135001 PRINTED ON THE LABEL ON THE SHARPS CONTAINER. SITUATION ANALYSIS # (B)(4) HAS BEEN OPENED TO ADDRESS THIS ISSUE. AS PER QE, A DHR REVIEW OF THE RISK MANAGEMENT FILE FOR THIS ISSUE SHOWS THAT THE RISK FOR THIS ISSUE IS LOW FOR EACH OF THE REPORTED LOT NUMBERS. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ SHARPS COLLECTOR HAD INCORRECT LABEL INFORMATION. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD¿ SHARPS COLLECTOR HAD INCORRECT LABEL INFORMATION. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997578 BD¿ SHARPS COLLECTOR SHARPS COLLECTORS FMI BECTON DICKINSON 8135001 10885403960109

    Patients

    Seq Age Sex Outcome Treatment
    1 Other