BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BENEHOLD MEDICAL TAPE STRIPS

    MDR report key: 2879295 · Received December 4, 2012

    Report

    Report Number
    3005360738-2012-00008
    Event Type
    Injury
    Date Received
    December 4, 2012
    Date of Event
    October 22, 2012
    Report Date
    December 3, 2012
    Manufacturer
    AVERY DENNISON BELGIE, BVBA
    Product Code
    KGX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED AND DEMONSTRATED THAT THE PRODUCT HAD MET SPECIFICATIONS. IT IS SUSPECTED THAT THE TAPE STRIP WAS NOT APPLIED PROPERLY, PER THE DIRECTIONS FOR USE, SINCE PREVIOUS INVESTIGATIONS HAVE DEMONSTRATED ADHESIVE PROPERTIES WITHIN DEVICE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A COMPLIANT WAS RECEIVED FROM A DIALYSIS CLINIC INVOLVING THE DISLODGEMENT OF A NEEDLE REPORTEDLY DUE TO POOR ADHESION OF A TAPE STRIP. THE TAPE STRIP PRODUCT IS USED TO ANCHOR A VENOUS NEEDLE DURING DIALYSIS THERAPY. THE VENOUS NEEDLE BECAME DISLODGED FROM THE WRIST DUE TO THE TAPE NOT ADHERING SUFFICIENTLY. THE PATIENT WAS UNATTENDED A THE TIME OF DISLODGEMENT AND THEREFORE LOST 200 CC OF BLOOD. TREATMENT WAS STOPPED. THE FACILITY INDICATED THAT THE PATIENT WAS TRANSPORTED TO A HOSPITAL. PATIENT WAS TREATED AND RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BENEHOLD MEDICAL TAPE STRIPS TAPE ON A SHEET KGX AVERY DENNISON BELGIE, BVBA C1203203

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention FISTULA NEEDLE