BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL

    MDR report key: 11143138 · Received January 8, 2021

    Report

    Report Number
    3005360738-2020-00006
    Event Type
    Injury
    Date Received
    January 8, 2021
    Date of Event
    November 17, 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 INDICATING THAT AN INFECTION OCCURRED AT A CATHETER SITE AFTER USING A CHLORASHIELD DRESSING AT A RESEARCH & TRAINING HOSPITAL WITHIN (B)(6). 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 EVALUATION FORM INDICATED THAT NO FOLLOW-UP CARE WAS REQUIRED TO ADDRESS THE REPORTED INFECTION AT THE CATHETER INSERTION SITE. FOLLOW-UP ATTEMPTS TO RECEIVE ANY ADDITIONAL COMPLAINT INFORMATION WERE UNSUCCESSFUL. BASED ON THE NATURE OF THIS INCIDENT, RETAIN SAMPLES WERE TESTED FOR PERFORMANCE CHARACTERISTICS. THE TEST RESULTS OBTAINED 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 INDICATING THAT AN INFECTION OCCURRED AT A CATHETER SITE AFTER USING A CHLORASHIELD DRESSING AT A RESEARCH & TRAINING HOSPITAL WITHIN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36939 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