BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL

    MDR report key: 11142920 · Received January 8, 2021

    Report

    Report Number
    3005360738-2020-00007
    Event Type
    Injury
    Date Received
    January 8, 2021
    Date of Event
    October 19, 2020
    Report Date
    January 6, 2021
    Manufacturer
    AVERY DENNISON BELGIE BVBA
    Product Code
    FRO
    PMA / PMN Number
    K113836
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AVERY DENNISON RECEIVED A COMPLAINT FROM A RESEARCH & TRAINING HOSPITAL WITHIN TURKEY INDICATING THAT A YELLOW MUCOUS LAYER FORMED UNDER A CHLORASHIELD DRESSING ON A PATIENT. THE YELLOW MUCOUS INDICATED THE PATIENT HAD DEVELOPED AT INFECTION AT THE CATHETER SITE. IT WAS ALSO NOTED THAT THE DRESSING LOST ADHESION IN THE CENTER AND AT THE EDGES OF THE DEVICE. THE BD CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL IS NOT INDICATED TO PREVENT INFECTIONS. AS STATED WITHIN THE INDICATIONS FOR USE OF THE DEVICE, THE CHLORASHIELD DRESSINGS ARE TO BE USED TO COVER AND PROTECT CATHETER SITES AND TO SECURE DEVICES TO THE SKIN. COMMON APPLICATIONS INCLUDE COVERING AND SECURING IV CATHETERS, OTHER INTRAVASCULAR CATHETERS AND PERCUTANEOUS DEVICES. THE INSTRUCTIONS FOR USE SPECIFY THAT NOT ALL SKIN TYPES OR CONDITIONS MAY ALLOW FOR FULL DRESSING ADHESION, THEREFORE, ADHESIVE PERFORMANCE MAY VARY BETWEEN PATIENTS. IT WAS REPORTED THAT THE PATIENT WAS TREATED FOR AN INFECTION. BASED ON THE NATURE OF THE INCIDENT, RETAIN SAMPLES WERE TESTED FOR PERFORMANCE CHARACTERISTICS. ALL THE RESULTS WERE FOUND TO BE WITHIN SPECIFICATIONS AND NO DEVICE MALFUNCTION WAS IDENTIFIED. IN ADDITION, AVERY DENNISON CONDUCTED A DEVICE HISTORY RECORD REVIEW OF THE REPORTED LOT. THE REVIEW CONFIRMED THAT THE PERFORMANCE CHARACTERISTICS WERE WITHIN SPECIFICATION AT THE TIME OF PRODUCT RELEASE.

    Description of Event or Problem · 1

    AVERY DENNISON RECEIVED A COMPLAINT FROM A RESEARCH & TRAINING HOSPITAL WITHIN TURKEY INDICATING THAT A YELLOW MUCOUS LAYER FORMED UNDER A CHLORASHIELD DRESSING ON A PATIENT. THE YELLOW MUCOUS INDICATED THE PATIENT HAD DEVELOPED AT INFECTION AT THE CATHETER SITE. IT WAS ALSO NOTED THAT THE DRESSING LOST ADHESION IN THE CENTER AND AT THE EDGES OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36145 BD CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL DRESSING, WOUND, DRUG FRO AVERY DENNISON BELGIE BVBA 410232 53354488

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other