BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD E-Z SCRUB

    MDR report key: 12032297 · Received June 21, 2021

    Report

    Report Number
    1710034-2021-00516
    Event Type
    Malfunction
    Date Received
    June 21, 2021
    Date of Event
    May 24, 2021
    Report Date
    September 1, 2021
    Manufacturer
    BECTON DICKINSON SANDY
    Product Code
    OJU
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF DHR DID NOT FIND ANY ATTRIBUTABLE DEFICIENCIES THAT WOULD LEAD TO THIS ISSUE. REVIEWED RETURN SAMPLE AND CONFIRMED THAT BLACK PARTICLES ON BRUSH. EXAMINATION OF RETURN SAMPLE IDENTIFIED THAT THE BLACK PARTICLES ARE EMBEDDED IN THE BRUSH. PER THE RISK MANAGEMENT DOCUMENT RM5983 V. 6(F), BURN MARKS OR DISCOLORATION IN MOLDED COMPONENTS CAN OCCUR AND THE SEVERITY OF THIS DEFECT IS S1 (NEGLIGIBLE) WITH THE POTENTIAL EFFECT IS CUSTOMER DISSATISFACTION. REVIEW OF THE BATCH RECORD SHOWS THAT PRODUCTION WAS PERFORMED AS SPECIFIED AND ALL IN-PROCESS QUALITY CHECKS MET ESTABLISHED SPECIFICATIONS, INCLUDING ATTRIBUTE CHECKS. REVIEW OF LOT HISTORY SHOW NO NON-CONFORMANCE EVENTS ISSUED FOR THIS LOT. ROOT CAUSE FOR THIS ISSUE CANNOT BE ESTABLISHED AT THIS TIME. PROBABLE ROOT CAUSE IS DISCOLORATION DUE TO MOLDING PROCESS (E.G., CONTAMINATION OF RAW MATERIAL, INCORRECT MIX RATIO, EXCESSIVE PRESSURE DUE TO INCORRECT PROCESS PARAMETER OR EQUIPMENT FAILURE, OR SCREW AND BARREL WEAR). FIRST COMPLAINT OF THIS LOT AND REVIEW OF DHR IN-PROCESS QUALITY CHECKS INDICATE THAT THIS IS A LOW OCCURRENCE WITH THIS LOT. ANY FUTURE COMPLAINTS WILL CONTINUE TO BE MONITORED FOR THIS LOT AND ASSESSED. H3 OTHER TEXT : SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT BLACK PARTICLES WERE FOUND ON THE BRUSH. THE SCRUB BRUSH APPEARS TO BE CONTAMINATED. UPON OPENING THE USER FOUND LARGE AMOUNTS OF BLACK PARTICLES ON THE BRUSH. I HAVE A SAMPLE HERE TO SEND IN FOR AN INVESTIGATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT BLACK PARTICLES WERE FOUND ON THE BRUSH. THE SCRUB BRUSH APPEARS TO BE CONTAMINATED. UPON OPENING THE USER FOUND LARGE AMOUNTS OF BLACK PARTICLES ON THE BRUSH. I HAVE A SAMPLE HERE TO SEND IN FOR AN INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934233 BD E-Z SCRUB IMPREGNATED PREOPERATIVE SCRUB BRUSHES OJU BECTON DICKINSON SANDY 0344980

    Patients

    Seq Age Sex Outcome Treatment
    1 Other