BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD E-Z SCRUB¿

    MDR report key: 17316264 · Received July 13, 2023

    Report

    Report Number
    1710034-2023-00785
    Event Type
    Malfunction
    Date Received
    July 13, 2023
    Date of Event
    June 14, 2023
    Report Date
    August 4, 2023
    Manufacturer
    CAREFUSION, INC
    Product Code
    GEC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TWO SAMPLES WERE AVAILABLE FOR EVALUATION. VISUAL EXAMINATION OF THE SAMPLES SHOWS A LIGHT BROWN COLORED PARTICLE OF THE SAME SIZE IN EACH OF THE TWO SAMPLES SENT. IN ADDITION, ONE UNIT HAS A WHITE, PARTIALLY TRANSLUCENT PARTICLE THAT MEASURES THE SAME LENGTH AND WIDTH OF THE BRISTLES IN THE BRUSH. THIS VERIFIED THE REPORTED ISSUE. THE PROBABLE ROOT CAUSE OF THE SMALL LIGHT BROWN FOREIGN MATTER IS LIKELY FOAM SPONGE DUST THAT ACCUMULATES DURING PRODUCTION. THE SECOND PARTICLE IS LIKELY A BRISTLE FROM THE BRUSH THAT WAS SEALED INTO THE PACKAGE. BOTH OF THESE PARTICLES ARE MATERIALS USED IN PRODUCTION; THEREFORE, THE RISK TO PRODUCT IS LOW. 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 MODERATE FOR THIS DEFECT. VISUAL INSPECT OF RETAINED UNITS. IDENTIFIED ALL UNITS WERE PRESENT AND NO DEFECTS WERE OBSERVED. THE RETAINED UNITS ARE ACCEPTABLE. CORRECTIVE ACTIONS INCLUDE EQUIPMENT COVERS TO MITIGATE THE SPREAD OF DUST ARE IN THE PROCESS OF BEING INSTALLED. COMPLAINTS WILL CONTINUE TO BE TRENDED AND EVALUATED FOR FURTHER ACTION, IF NEEDED.

    Additional Manufacturer Narrative · 0

    12JUL2023: PR 8203 344 INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. IMDRF ANNEX E CODE HEALTH EFFECT ¿ CLINICAL CODE: E2403. IMDRF ANNEX A CODE MEDICAL DEVICE PROBLEM CODE: A18.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THERE WERE DEBRIS FOUND IN PACKAGE SEALING SURFACE. VERBATIM: DEBRIS FOUND IN PACKAGE SEALING SURFACE. ADDITIONAL INFORMATION RECEIVED ON 16-JUNE-2023. 1. ARE YOU ABLE TO PROVIDE THE DATE OF INCIDENT? 6/14/2023. 2. WAS THIS NOTED UPON RECEIPT? WAS THE PRODUCT RECEIVED IN THIS CONDITION? NO, YES. 3. PLEASE CONFIRM IF THERE WAS PATIENT INVOLVEMENT. IF SO, WERE THERE ANY ADVERSE EVENT OR SERIOUS INJURY? NO, NO. 4. WAS THE DEBRIS EMBEDDED ON THE PACKAGING OR CAN BE REMOVED? YES, YES.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THERE WERE DEBRIS FOUND IN PACKAGE SEALING SURFACE. VERBATIM: DEBRIS FOUND IN PACKAGE SEALING SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281324 BD E-Z SCRUB¿ IMPREGNATED PREOPERATIVE SCRUB BRUSHES (3% CHLOROXYLENOL (PCMX) GEC CAREFUSION, INC 3004854

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown