BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD E-Z SCRUB

    MDR report key: 12506374 · Received September 21, 2021

    Report

    Report Number
    1710034-2021-00831
    Event Type
    Malfunction
    Date Received
    September 21, 2021
    Date of Event
    August 27, 2021
    Report Date
    September 30, 2021
    Manufacturer
    BD SANDY
    Product Code
    GEC
    UDI-DI
    00382903716036
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CAUSE OF THE FOREIGN MATTER IS LIKELY A DEFECTIVE SECTION OF THE FOAM SPONGE (BURNT SPONGE) PER THE FTIR ANALYSIS PERFORMED. BATCH RECORD WAS REVIEWED, INCLUDING ALL ATTRIBUTE DATA, AND NO DEVIATIONS OR DISCREPANCIES WERE NOTED THAT WOULD CONTRIBUTE OR CAUSE THIS ISSUE. REVIEW OF RISK MANAGEMENT DOCUMENT SHOWS THAT SEVERITY RATING IS MINOR FOR THIS DEFECT. THIS IS THE FIRST COMPLIANT REPORTED FOR THIS LOT. COMPLAINTS WILL CONTINUE TO BE TRENDED AND EVALUATED FOR FURTHER ACTION, IF NEEDED. NO CAPA REQUIRED. H3 OTHER TEXT : SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SPONGE BRUSH SCRUB APPEARS TO HAVE MOLD ON THE BRUSH.   VERBATIM: WE HAD THE FOLLOWING ISSUE- DO WE NEED TO PULL THIS LOT? WE STILL HAVE THE ITEM. "WHEN IT WAS OPENED IN A CASE AND IT APPEARS TO HAVE MOLD ON THE SCRUB BRUSH. LOT NUMBER 0328903" CUSTOMER NOTIFIED ME BY EMAIL ON (B)(6) 2021 OF THIS ISSUE. AND IN THE E-MAIL SAID THEY STILL HAVE THE PRODUCT ITEM. CUSTOMER IS ALSO ASKING WHAT SHOULD THEY DO WITH THE FOLLOWING SCRUB BRUSHES WITH THE SAME LOT#! I BELIEVE THIS EVENT OCCURRED ON (B)(6) 2021 AS THIS IS WHEN I WAS NOTIFIED.

    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 THAT SPONGE BRUSH SCRUB APPEARS TO HAVE MOLD ON THE BRUSH. ¿ VERBATIM: WE HAD THE FOLLOWING ISSUE- DO WE NEED TO PULL THIS LOT? WE STILL HAVE THE ITEM. "WHEN IT WAS OPENED IN A CASE AND IT APPEARS TO HAVE MOLD ON THE SCRUB BRUSH. LOT NUMBER 0328903" CUSTOMER NOTIFIED ME BY EMAIL ON 8/27 OF THIS ISSUE. AND IN THE E-MAIL SAID THEY STILL HAVE THE PRODUCT ITEM. CUSTOMER IS ALSO ASKING WHAT SHOULD THEY DO WITH THE FOLLOWING SCRUB BRUSHES WITH THE SAME LOT#! I BELIEVE THIS EVENT OCCURRED ON 8/27 AS THIS IS WHEN I WAS NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1403468 BD E-Z SCRUB IMPREGNATED PREOPERATIVE SCRUB BRUSHES (3% CHLOROXYLENOL (PCMX) GEC BD SANDY 371603 0328903 00382903716036

    Patients

    Seq Age Sex Outcome Treatment
    1 Other