BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD E-Z SCRUB

    MDR report key: 11499277 · Received March 16, 2021

    Report

    Report Number
    1710034-2021-00196
    Event Type
    Injury
    Date Received
    March 16, 2021
    Date of Event
    February 4, 2021
    Report Date
    August 3, 2021
    Manufacturer
    BD SANDY
    Product Code
    GEC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF THE MANUFACTURING BATCH RECORD AND LABORATORY RESULTS DID NOT DETERMINE ROOT CAUSE FOR THIS ISSUE. REVIEW OF PREVIOUS COMPLAINTS DID NOT IDENTIFY PREVIOUS COMPLAINTS FOR THIS LOT. REVIEW OF THE FINISHED GOOD BATCH RECORD, PART NUMBER 371163, LOT 0133746, WAS PERFORMED FOR ANY DISCREPANCIES OR DEVIATIONS, INCLUDING EXCESSIVE SOAP WEIGHT, THAT WOULD CONTRIBUTE TO THIS ISSUE. NO DEVIATIONS OR DISCREPANCIES WERE IDENTIFIED DURING THE REVIEW OF THE BATCH RECORD. REVIEW OF VENDOR¿S COA AND BD SANDY COA DID NOT IDENTIFY ANY OUT OF SPECIFICATIONS OR DISCREPANCIES THAT WOULD CONTRIBUTE TO THIS ISSUE. BD WILL CONTINUE TO TRACK AND TREND FOR THIS FAILURE MODE. H3 OTHER TEXT : SEE NARRATIVE SECTION.

    Description of Event or Problem · 0

    THE CENTRUM DISTRIBUTOR REPORTS THAT SURGEON LSMF FROM THE COLON AND RECTUM AREA OF THE CENTRAL MILITARY HOSPITAL REPORTED THAT SHE HAS PRESENTED ERYTHEMA ON HER HANDS AFTER USING THE SURGICAL BRUSH CATALOG 371163 (PCMX 3%) FOR WHICH SHE REQUESTS THE CHANGE OF CATALOG TO 371073 (CHG 4%). IN ADDITION, SHE STATES THAT THE EPIDEMIOLOGY AREA OF THE HOSPITAL CARRIED OUT A STUDY WHERE THE PRESENCE OF MICROBIOTA WAS EVEN DETECTED IN THE AREA ALREADY WASHED WITH THE BRUSH. THIS CLAIM WAS OPENED TO INVESTIGATE: EYTHEMA. COMPLAINT PR (B)(4) WAS OPENED TO INVESTIGATE THE PRESENCE OF MICROBIOTA.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CENTRUM DISTRIBUTOR REPORTS THAT SURGEON LSMF FROM THE COLON AND RECTUM AREA OF THE CENTRAL MILITARY HOSPITAL REPORTED THAT SHE HAS PRESENTED ERYTHEMA ON HER HANDS AFTER USING THE SURGICAL BRUSH CATALOG 371163 (PCMX 3%) FOR WHICH SHE REQUESTS THE CHANGE OF CATALOG TO 371073 (CHG 4%). IN ADDITION, SHE STATES THAT THE EPIDEMIOLOGY AREA OF THE HOSPITAL CARRIED OUT A STUDY WHERE THE PRESENCE OF MICROBIOTA WAS EVEN DETECTED IN THE AREA ALREADY WASHED WITH THE BRUSH. THIS CLAIM WAS OPENED TO INVESTIGATE : EYTHEMA. COMPLAINT PR (B)(4) WAS OPENED TO INVESTIGATE THE PRESENCE OF MICROBIOTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392601 BD E-Z SCRUB IMPREGNATED PREOPERATIVE SCRUB BRUSHES (3% CHLOROXYLENOL (PCMX)) GEC BD SANDY 0133746

    Patients

    Seq Age Sex Outcome Treatment
    1 Other