BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD E-Z SCRUB

    MDR report key: 11097623 · Received December 30, 2020

    Report

    Report Number
    1710034-2020-00839
    Event Type
    Malfunction
    Date Received
    December 30, 2020
    Date of Event
    December 3, 2020
    Report Date
    February 10, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    GEC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. RETAIN SAMPLES WERE INSPECTED AND NOTHING WAS FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED. COMPLAINTS ARE TRACKED AND TRENDED. H3 OTHER TEXT: SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE IS A LACK OF CHLORHEXIDINE ON THE SPONGE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE IS A LACK OF CHLORHEXIDINE ON THE SPONGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1561901 BD E-Z SCRUB CHLORAHEXIDINE GLUCONATE SOLUTION GEC BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9323782

    Patients

    Seq Age Sex Outcome Treatment
    1 Other