BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD E-Z SCRUB

    MDR report key: 16780986 · Received April 20, 2023

    Report

    Report Number
    1710034-2023-00432
    Event Type
    Malfunction
    Date Received
    April 20, 2023
    Date of Event
    March 7, 2023
    Report Date
    May 30, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    GEC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE PHOTO WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE PHOTO, IT DOES APPEAR THAT THERE IS AN ORGANIC GROWTH ON THE OUTSIDE OF THE SHIPPERS FACING THE MIDDLE OF THE PALLET. NO OTHER PHOTOS WERE RECEIVED TO SHOW IF THE SHIPPERS FACING OUTWARD WERE AFFECT AND NO SAMPLES WERE RECEIVED TO CONFIRM IF THE GROWTH IS MOLD. THIRTY (30) RETAINED UNITS WERE VISUAL INSPECTED. NO MOLD OR FOREIGN MATTER WAS FOUND ON THE PACKAGE UNITS OR DISPENSER. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. THE ROOT CAUSE IS UNDETERMINED. THE INVESTIGATION DID NOT IDENTIFY CONCLUSIVE EVIDENCE OF WHERE OR HOW THE SHIPPERS CAME IN CONTACT WITH MOLD. A PROBABLE ROOT CAUSE COULD BE THE TEMPERATURE AND HUMIDITY OF THE AREA THE PRODUCT WAS SHIPPED TO. THE SHIPMENT IS DONE VIA BOAT IN A METAL SHIPPING CONTAINER. THERE ARE NO ENVIRONMENTAL CONTROLS IN THE CONTAINER TO PREVENT AGAINST CONDENSATION BUILD UP ON PRODUCT FROM THE INCREASED HUMIDITY OF THE AREA. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). INITIAL MDR. A FOLLOW UP WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    RECEIVED BY CUSTOMER WITH VISIBLE MOLD ON BD BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1207096 BD E-Z SCRUB BD E-Z SCRUB GEC BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 2130571

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown