BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD E-Z SCRUB¿

    MDR report key: 17604247 · Received August 23, 2023

    Report

    Report Number
    1710034-2023-00941
    Event Type
    Malfunction
    Date Received
    August 23, 2023
    Date of Event
    August 3, 2023
    Report Date
    September 13, 2023
    Manufacturer
    CAREFUSION, INC
    Product Code
    GEC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE WAS AVAILABLE FOR EVALUATION. VISUAL EXAMINATION OF THE SAMPLE SHOWS THE APPEARANCE OF A SMALL AMOUNT OF BLACK SUBSTANCE ON THE PICK AND THE FILM PACKAGING. THIS VERIFIED THE REPORTED ISSUE. THE MOST PROBABLE ROOT CAUSE OF THE FOREIGN MATTER IS THE MOLDING PROCESS OF THE NAIL PICK BY AN UNKNOWN CAUSE. THE SUBSTANCE RESEMBLES THE GREASE USED IN THE MOLDS FOR MAKING THE NAIL PICKS. THE GREASE USED IS PHARMACEUTICAL FOOD GRADE MATERIAL. PROCESS SPECIFICATIONS AND IN-PROCESS INSPECTIONS ARE ESTABLISHED TO MITIGATE RISK OF FOREIGN MATTER TO THE PRODUCT; 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 30 RETAINED UNITS WAS COMPLETED AND IDENTIFIED ALL UNITS WERE PRESENT AND NO DEFECTS WERE OBSERVED. THE RETAINED UNITS ARE ACCEPTABLE. THIS IS THE FIRST COMPLIANT REPORTED FOR THIS LOT. COMPLAINTS WILL CONTINUE TO BE TRENDED AND EVALUATED FOR FURTHER ACTION, IF NEEDED. NO FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 0

    (B)(6) 2023: PR 8203 344INITIAL 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

    VERBATIM: WE HAVE RECEIVED A QUALITY COMPLAINT ON PRODUCT SOLD TO OUR CUSTOMER. PLEASE CONTACT THE CUSTOMER AND CC DISTRIBUTEDQUALITY (B)(6) ON ANY FUTURE COMMUNICATION. INJURIES OR ADVERSE EVENT: NO. ITEM: (B)(4). QUANTITY AFFECTED: 1 EACH SERIAL/LOT NUMBER: (B)(6). PO : (B)(6). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES REPORTED ISSUE: FOREIGN MATTER, DEBRIS CUSTOMER DISPOSITION REQUEST: REPLACEMENT. ADDITIONAL INFORMATION RECEIVED ON 21-AUG-2023: 1. CAN YOU PLEASE ADVISE WHERE THE PARTICULATE WAS FOUND, WAS IT ON THE PACKAGING OR THE APPLICATOR? IF THE APPLICATOR, PLEASE DESCRIBE ON WHICH PART, WAS IT ON THE BARREL, INSIDE THE BARREL OR ON THE FOAM PAD? INSIDE PACKAGE, ON BRUSH, PACKAGING AND FINGERNAIL PICK. 2. DO YOU HAVE ANY PHOTOS TO SHOW THE REPORTED ISSUE? SEE ATTACHED ABOVE. 3. WHAT IS THE FULL NAME AND ADDRESS OF THE FACILITY FOR WHERE THIS OCCURRED? MEDICAL CENTER: 4. WHAT IS THE DATE OF EVENT? JULY. 5. PLEASE ADVISE THE SAMPLE STATUS AS THERE WAS NO SAMPLE MOVEMENT PER THE TRACKING STATUS. SAMPLE IS AVAILABLE.

    Description of Event or Problem · 0

    VERBATIM: WE HAVE RECEIVED A QUALITY COMPLAINT ON PRODUCT SOLD TO OUR CUSTOMER. PLEASE CONTACT THE CUSTOMER AND CC (B)(6) ON ANY FUTURE COMMUNICATION. INJURIES OR ADVERSE EVENT: NO. ITEM: 371163. QUANTITY AFFECTED: 1 EACH. SERIAL/LOT NUMBER: (B)(6). PO : 4516282681. ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: FOREIGN MATTER, DEBRIS. CUSTOMER DISPOSITION REQUEST: REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364587 BD E-Z SCRUB¿ IMPREGNATED PREOPERATIVE SCRUB BRUSHES (3% CHLOROXYLENOL (PCMX) GEC CAREFUSION, INC 2152291

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other