BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD E-Z SCRUB¿

    MDR report key: 16817688 · Received April 26, 2023

    Report

    Report Number
    1710034-2023-00447
    Event Type
    Malfunction
    Date Received
    April 26, 2023
    Date of Event
    April 5, 2023
    Report Date
    July 12, 2023
    Manufacturer
    CAREFUSION, INC
    Product Code
    GEC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE SAMPLE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION OF THE SAMPLE IDENTIFIED FOREIGN MATTER ON THE PRODUCT WHICH VERIFIES THE REPORTED ISSUE. FTIR TESTING WAS DONE AT THE VERNON HILLS LOCATION TO IDENTIFY THE FOREIGN MATERIAL. THE TEST RESULTS STATE THAT THE MATERIAL IS A TYPE OF POLYPROPYLENE. LOW DENSITY POLYPROPYLENE IS A MATERIAL USED TO MAKE THE SCRUB BRUSH. OCCASIONALLY, A LOOSE PARTICLE FROM THE MOLDING PROCESS REMAINS WITH THE BRUSH THROUGHOUT THE PRODUCTION AND PACKAGING PROCESS WHICH IS THE MOST PROBABLE SOURCE OF THIS ISSUE. BATCH RECORD REVIEW SHOWS THAT ALL ATTRIBUTE DATE 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 MODERATE FOR THIS DEFECT WITH POTENTIAL EFFECTS OF FAILURE BEING CUSTOMER DISSATISFACTION AND PATIENT INFECTIONS/COMPLICATIONS. NO FURTHER ACTIONS ARE REQUIRED. COMPLAINTS WILL CONTINUE TO BE TRACKED AND TRENDED.

    Additional Manufacturer Narrative · 0

    ON 26APR202: 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: E2403. IMDRF ANNEX A CODE MEDICAL DEVICE PROBLEM CODE: A18.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THEY FOUND MOLD OR SOMETHING GROWING INSIDE, WHEN THE PRODUCT WAS OPENED. VERBATIM: BELOW IS INFO & PHOTOS OF A SCRUB PACK WITH MOLD OR SOMETHING GROWING INSIDE WHEN IT WAS OPENED. LOOKS LIKE MOLD IN UPPER LEFT CORNER OF THE PACK. ADDITIONAL INFORMATION RECEIVED 07-APR-2023. WHAT IS THE DATE OF EVENT? 4/5/23. THE LOT NUMBER PROVIDED OF 2305243, WAS NOT ABLE TO BE FOUND WITHIN OUR SYSTEM FOR THE PRODUCT WITH MATERIAL # 371163. UPON REVIEW OF THE ATTACHED PHOTO OF THE PRODUCT, WE DID OBSERVE THE LOT NUMBER AND FOUND IT TO BE 2305248, WHICH WAS ALSO SEARCHED WITHIN OUR SYSTEM BUT WAS FOUND FOR TO BE A MATCH FOR THE MATERIAL # 371163. CAN YOU PLEASE RE CHECK THE PRODUCT PACKAGING AND CONFIRM THE LOT NUMBER PREVIOUSLY PROVIDED VS OUR FINDINGS? LOT # IS 2305248.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THEY FOUND MOLD OR SOMETHING GROWING INSIDE, WHEN THE PRODUCT WAS OPENED. VERBATIM: BELOW IS INFO & PHOTOS OF A SCRUB PACK WITH MOLD OR SOMETHING GROWING INSIDE WHEN IT WAS OPENED. LOOKS LIKE MOLD IN UPPER LEFT CORNER OF THE PACK. ADDITIONAL INFORMATION RECEIVED 07-APR-2023. WHAT IS THE DATE OF EVENT? (B)(6) 2023. THE LOT NUMBER PROVIDED OF 2305243, WAS NOT ABLE TO BE FOUND WITHIN OUR SYSTEM FOR THE PRODUCT WITH MATERIAL # 371163. UPON REVIEW OF THE ATTACHED PHOTO OF THE PRODUCT. WE DID OBSERVE THE LOT NUMBER AND FOUND IT TO BE 2305248, WHICH WAS ALSO SEARCHED WITHIN OUR SYSTEM BUT WAS FOUND FOR TO BE A MATCH FOR THE MATERIAL # 371163. CAN YOU PLEASE RE CHECK THE PRODUCT PACKAGING AND CONFIRM THE LOT NUMBER PREVIOUSLY PROVIDED VS OUR FINDINGS? LOT # IS 2305248.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163579 BD E-Z SCRUB¿ IMPREGNATED PREOPERATIVE SCRUB BRUSHES (3% CHLOROXYLENOL (PCMX) GEC CAREFUSION, INC 2305248

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown