BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD E-Z SCRUB¿

    MDR report key: 12775290 · Received November 8, 2021

    Report

    Report Number
    1710034-2021-00961
    Event Type
    Malfunction
    Date Received
    November 8, 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

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

    Additional Manufacturer Narrative · 0

    SAMPLE OR PHOTO NOT SUBMITTED FOR REVIEW. BATCH RECORD REVIEW SHOWS THAT ALL ATTRIBUTED DATA PASSED QUALITY CHECKS THROUGHOUT THE PRODUCTION OF THE LOT, 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. SIMILAR COMPLAINT (B)(4) IDENTIFIED THE FOREIGN MATTER TO LIKELY BE PART OF THE FOAM SPONGE THAT WAS BURNT AND NOT A FOREIGN OBJECT TO THE SPONGE. DUE TO LOW COMPLAINT HISTORY FOR THIS LOT, DATA FROM IN-PROCESS QUALITY CHECKS DURING PRODUCTION, AND QUALITY CONTROL LABORATORY DATA, NO FURTHER ACTION IS RECOMMENDED AT THIS TIME. COMPLAINTS WILL CONTINUE TO BE TRENDED AND EVALUATED FOR FURTHER ACTION, IF NEEDED. NO FURTHER ACTIONS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PACK WAS NOTED TO HAVE BLACK DEBRIS ON THE SPONGE. 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 NOTED TO HAVE BLACK DEBRIS ON THE SPONGE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1674280 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