BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL

    MDR report key: 11142923 · Received January 8, 2021

    Report

    Report Number
    3005360738-2020-00008
    Event Type
    Injury
    Date Received
    January 8, 2021
    Date of Event
    November 13, 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 (B)(6) INDICATING THAT A CHLORASHIELD DRESSING HAD STUCK TO THE CATHETER OF A PEDIATRIC PATIENT. THEREFORE, THE CLINICIAN EXPERIENCED DIFFICULTY REMOVING THE DRESSING FROM THE CATHETER RESULTING IN SUTURE DAMAGE. IT WAS ALSO STATED THAT DUE TO THE STICKINESS OF THE DRESSING, AND THE DIFFICULTY IN ITS REMOVAL, THE PATIENT SUTURES WERE DAMAGED RESULTING IN A CATHETER-RELATED INFECTION. FOLLOW-UP COMMUNICATION WITH THE CLINIC WITHIN (B)(6) REVEALED THAT THE NURSE WAS UNSURE ABOUT THE SOURCE OF THE PATIENT'S INFECTION SINCE THE PATIENT'S PRE-EXISTING CONDITION MAY HAVE CAUSED THE INFECTION. AN ANTIBIOTIC TREATMENT WAS DELIVERED TO THE PATIENT TO TREAT THE INFECTION NOTED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL IN A HEALTHY CONDITION FOLLOWING TREATMENT. 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 (B)(6) INDICATING THAT A CHLORASHIELD DRESSING HAD STUCK TO THE CATHETER OF A PEDIATRIC PATIENT. THEREFORE, THE CLINICIAN EXPERIENCED DIFFICULTY REMOVING THE DRESSING FROM THE CATHETER RESULTING IN SUTURE DAMAGE. IT WAS ALSO STATED THAT DUE TO THE STICKINESS OF THE DRESSING, AND THE DIFFICULTY IN ITS REMOVAL, THE PATIENT SUTURES WERE DAMAGED RESULTING IN A CATHETER-RELATED INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36366 BD CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL DRESSING, WOUND, DRUG FRO AVERY DENNISON BELGIE BVBA 410232 53354488

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other