BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIVA ANTIMICROBIAL HEMOSTATIC IV DRESSING

    MDR report key: 8393988 · Received March 6, 2019

    Report

    Report Number
    8393988
    Event Type
    Malfunction
    Date Received
    March 6, 2019
    Date of Event
    March 5, 2019
    Report Date
    March 5, 2019
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    FRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATCH ITSELF IS COMING APART AND NOT REMAINING IN ONE PIECE WITH USE. THE PATCH COMES APART, STICKS TO PACKAGING, LAYERS PEEL APART, ETC. MANUFACTURER RESPONSE FOR ANTIMICROBIAL HEMOSTATIC IV DRESSING, GUARD IVA (PER SITE REPORTER). THEY REMOVED PRODUCT FROM HOSPITAL AND REPLACED WITH ALTERNATIVE DEVICE. MULTIPLE LOT NUMBERS IDENTIFIED. THIS IS THREE LOT NUMBERS OF MANY: JUCSF230, JUCUF003, ASBYT002 250804.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189035 GUARDIVA ANTIMICROBIAL HEMOSTATIC IV DRESSING DRESSING, WOUND, DRUG FRO BARD ACCESS SYSTEMS, INC. FP-23-AD008 JUCSF230

    Patients

    Seq Age Sex Outcome Treatment
    1