BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD E-Z SCRUB

    MDR report key: 12825295 · Received November 17, 2021

    Report

    Report Number
    1710034-2021-00960
    Event Type
    Malfunction
    Date Received
    November 17, 2021
    Date of Event
    August 26, 2021
    Report Date
    December 28, 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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES OR PHOTOS WERE PROVIDED FOR EVALUATION. AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE AT THIS TIME. REVIEW OF DEVICE HISTORY REVIEW DID NOT FIND ANY ATTRIBUTABLE DEFICIENCIES THAT WOULD LEAD TO THIS ISSUE. REVIEW OF RISK MANAGEMENT DOCUMENT SHOWS THAT SEVERITY FOR STERILE PRODUCTS FOR LEAKING SEAL IS ACCEPTABLE WITH A REMOTE OCCURRENCE FOR THIS DEFECT AND PATIENT INFECTIONS/COMPLICATIONS BEING THE POTENTIAL FAILURE MODE. POSSIBLE CAUSES OF THIS ISSUE COULD BE RESULT OF INCORRECT SET UP OR REJECTED PRODUCT BEING INADVERTENTLY INTRODUCED BACK INTO THE PRODUCT STREAM. REVIEW OF THE BATCH RECORD SHOWS THAT PRODUCTION WAS PERFORMED AS SPECIFIED AND ALL IN-PROCESS QUALITY CHECKS MET ESTABLISHED SPECIFICATIONS. REVIEW OF LOT HISTORY SHOW NO NON-CONFORMANCE EVENTS ISSUED FOR THIS LOT. ROOT CAUSE FOR THIS ISSUE CANNOT BE ESTABLISHED AT THIS TIME. ANY FUTURE COMPLAINTS WILL CONTINUE TO BE MONITORED FOR THIS LOT AND ASSESSED. H3 OTHER TEXT : SEE NARRATIVE BELOW.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PACK WAS OPENED. VERBATIM: DESCRIBE THE EVENT OR PROBLEM: BD E-Z SCRUB 160 SURGICAL SCRUB BRUSH/SPONGE WITH NAIL CLEANER PACK WAS OPENED AND NOTED TO HAVE BLACK DEBRIS ON THE SPONGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PACK WAS OPENED. DESCRIBE THE EVENT OR PROBLEM: BD E-Z SCRUB 160 SURGICAL SCRUB BRUSH/SPONGE WITH NAIL CLEANER PACK WAS OPENED AND NOTED TO HAVE BLACK DEBRIS ON THE SPONGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1729808 BD E-Z SCRUB IMPREGNATED PREOPERATIVE SCRUB BRUSHES (3% CHLOROXYLENOL (PCMX)) GEC BD SANDY 371603 0328903 00382903716036

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other