BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD CHLORASHIELD(TM) IV DRESSING WITH CHG ANTIMICROBIAL

    MDR report key: 6894024 · Received September 26, 2017

    Report

    Report Number
    3005360738-2017-00002
    Event Type
    Injury
    Date Received
    September 26, 2017
    Date of Event
    August 1, 2017
    Report Date
    September 26, 2017
    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

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT INVOLVED THE USE OF A DRESSING TO COVER AN IV CATHETER ON A PATIENT UNDERGOING DIALYSIS. A CLINICIAN FROM (B)(6), REPORTED THAT THE SECRETIONS OBSERVED AT AN IV CATHETER SITE, UNDER A DRESSING, WERE POSITIVE FOR KLEBSIELLA PNEUMONIAE. THE DEVICE WAS NOT RETURNED AND WAS DISCARDED FOLLOWING USE. THE CLINICIAN REPORTED THE IV SITE WAS PREPARED BY USING AN ALCOHOL PAD TO WIPE THE AREA OF INSERTION. THE LOT NUMBER OF THE REPORTED DEVICE WAS PROVIDED AND AN INVESTIGATION WAS CONDUCTED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED PERFORMANCE DATA WAS WITHIN DEVICE SPECIFICATIONS. TESTING OF RETAIN SAMPLES FROM THE SPECIFIED LOT CONFIRMED PROPER DEVICE PERFORMANCE. THE DRESSING IS NOT INTENDED TO REDUCE THE PROBABILITY OF INFECTION IN PATIENTS. THE INSTRUCTIONS FOR USE INCLUDED WITH THE DEVICE CONTAINS THE FOLLOWING STATEMENT: "REDUCTION IN THE COLONIZATION OR MICROBIAL GROWTH ON THE DEVICE HAS NOT BEEN SHOWN TO CORRELATE WITH A REDUCTION IN INFECTIONS IN PATIENTS. CLINICAL STUDIES TO EVALUATE REDUCTION IN INFECTION HAVE NOT BEEN PERFORMED". FURTHERMORE, THE IFU CONTAINS A PRECAUTION WHICH STATES "THE DRESSING SHOULD NOT BE PLACED OVER INFECTED WOUNDS. THIS DEVICE IS NOT INTENDED TO TREAT CATHETER-RELATED BLOOD STREAM INFECTIONS (CRBSIS) OR OTHER PERCUTANEOUS DEVICE-RELATED INFECTIONS". THE RESULTING INVESTIGATION REVEALED THERE WAS NO DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    THROUGH A DISTRIBUTOR, A CLINICIAN REPORTED AN INCIDENT INVOLVING A SECRETION THAT WAS OBSERVED AT THE EXIT SITE OF THE IV CATHETER UNDER A CHLORASHIELD IV DRESSING. THE INCIDENT WAS OBSERVED IN A DIALYSIS PATIENT. THE SECRETION WAS CULTURED AND TESTED POSITIVE FOR KLEBSIELLA PNEUMONIAE. NO FURTHER TREATMENT WAS REQUIRED. THE INCIDENT WAS REPORTED TO THE MANUFACTURER ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674184 BD CHLORASHIELD(TM) IV DRESSING WITH CHG ANTIMICROBIAL DRESSING, WOUND, DRUG FRO AVERY DENNISON BELGIE BVBA 410132 32503704

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other IV CATHETER