BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD E-Z SCRUB

    MDR report key: 16870484 · Received May 4, 2023

    Report

    Report Number
    1710034-2023-00466
    Event Type
    Injury
    Date Received
    May 4, 2023
    Date of Event
    April 27, 2023
    Report Date
    July 17, 2023
    Manufacturer
    BD SANDY
    Product Code
    GEC
    UDI-DI
    00382903716036
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. IMDRF ANNEX E CODE HEALTH EFFECT ¿ CLINICAL CODE: E1714. IMDRF ANNEX A CODE MEDICAL DEVICE PROBLEM CODE: A24.

    Additional Manufacturer Narrative · 0

    NO SAMPLES OR PHOTOS WERE AVAILABLE FOR EVALUATION. AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE AT THIS TIME. THE SUSPECTED PRODUCT DOES NOT CONTAIN ANY SURGICAL SCRUB SOLUTIONS OR ACCELERANTS. THE SPONGE, HOLDER, BRUSH BRISTLES AND THE NAIL PICK ARE ALL MADE OF POLYURETHANE. THESE INGREDIENTS DO NOT HAVE AN ADHERENT CORRELATION TO ANY ALLERGIC REACTIONS BD HAS INVESTIGATED IN THE PAST. NO FURTHER ACTIONS ARE REQUIRED. THIS FAILURE MODE WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT ONE OF NURSE'S COLLEAGUES DEVELOPED A RASH ON ARMS AND THEY ARE NOT SURE IF IT CAME FROM THE SCRUBBRUSH OR THE GOWN HE WAS WEARING. VERBATIM: QUESTION: NURSE WANTING TO KNOW IF THERE ARE ANY ACCELERANTS IN THE EZ SCRUB BRUSH (REF 371603, LOT# 3214288).STATES ONE OF HER COLLEAGUES DEVELOPED A RASH ON HIS ARMS AND THEY ARE NOT SURE IF IT CAME FROM THE SCRUB BRUSH OR THE GOWN HE WAS WEARING. RESPONSE: EXPLAINED 371603 DOES NOT CONTAIN ANY SURGICAL SCRUB SOLUTIONS OR ACCELERANTS. INFORMED THE SPONGE ISMADE OF POLYURETHANE, THE HOLDER IS MADE OF POLYPROPYLENE, AND THE BRISTLES OF THE BRUSH ARE POLYETHELYNE.THE NAIL PICK IS MADE OF HIGH DENSITY POLYETHTLENE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT ONE OF NURSE'S COLLEAGUES DEVELOPED A RASH ON ARMS AND THEY ARE NOT SURE IF IT CAME FROM THE SCRUBBRUSH OR THE GOWN HE WAS WEARING. VERBATIM: QUESTION NURSE WANTING TO KNOW IF THERE ARE ANY ACCELERANTS IN THE EZ SCRUB BRUSH (REF (B)(4), LOT# 3214288).STATES ONE OF HER COLLEAGUES DEVELOPED A RASH ON HIS ARMS AND THEY ARE NOT SURE IF IT CAME FROM THE SCRUBBRUSH OR THE GOWN HE WAS WEARING. RESPONSE EXPLAINED 371603 DOES NOT CONTAIN ANY SURGICAL SCRUB SOLUTIONS OR ACCELERANTS. INFORMED THE SPONGE IS MADE OF POLYURETHANE, THE HOLDER IS MADE OF POLYPROPYLENE, AND THE BRISTLES OF THE BRUSH ARE POLYETHYLENE. THE NAIL PICK IS MADE OF HIGH DENSITY POLYETHYLENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533271 BD E-Z SCRUB BD E-Z SCRUB GEC BD SANDY 371603 UNKNOWN 00382903716036

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other