BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPATCH, UNKNOWN SIZE/PRODUCT ID

    MDR report key: 7139754 · Received December 21, 2017

    Report

    Report Number
    2648988-2017-00060
    Event Type
    Injury
    Date Received
    December 21, 2017
    Report Date
    December 4, 2017
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    FRO
    PMA / PMN Number
    K003229
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED ON 01/19/2018. THE UNITS INVOLVED IN THE REPORTED INCIDENTS WERE USED DURING A MEDICAL STUDY PERFORMED FROM 2004 TO 2005 AND ARE NOT AVAILABLE TO PERFORM A FAILURE ANALYSIS. THEREFORE, THE REPORTED CONDITION OF BACTEREMIA (INFECTION) IS UNCONFIRMED.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    PEDIATR NEPHROL (2009) PUBLISHED "PROPHYLAXIS OF CATHETER-RELATED BACTEREMIA USING TISSUE PLASMINOGEN ACTIVATOR¿TOBRAMYCIN LOCKS". THE CHARTS OF 56 CHILDREN UNDERGOING LONG-TERM HEMODIALYSIS IN THE PEDIATRIC DIALYSIS UNIT OF THE UNIVERSITY OF MIAMI/HOLTZ CHILDREN¿S HOSPITAL FROM 1 JANUARY 2004 TO 15 AUGUST 2005 WERE REVIEWED RETROSPECTIVELY. DURING THIS PERIOD, 45/56 (80%) CHILDREN HAD TUNNELED CUFFED CATHETERS AS VASCULAR ACCESS FOR AT LEAST SOME PORTION OF THE STUDY. PATIENTS UNDERWENT DIALYSIS THREE TO FOUR TIMES PER WEEK. THE EXIT SITE WAS CLEANSED WITH POVIDONE¿IODINE SOLUTION AND CHLORHEXIDINEIMPREGNATED DRESSING (BIOPATCH®, JOHNSON & JOHNSON MEDICAL INC.) WAS APPLIED WEEKLY. ELEVEN PATIENTS HAD AN ARTERIOVENOUS GRAFT/FISTULA AS THEIR VASCULAR ACCESS. THE PRIMARY ETIOLOGIES FOR END-STAGE RENAL DISEASE: OBSTRUCTIVE NEPHROPATHY/RENAL DYSPLASIA HYPOPLASIA/NEUROGENIC BLADDER IN 20 PATIENTS, CHRONIC GLOMERULONEPHRITIS IN 12 PATIENTS, LUPUS NEPHRITIS/VASCULITIS IN 10 PATIENTS, HUMAN IMMUNODEFICIENCY VIRUS (HIV) NEPHROPATHY IN 8 PATIENTS, AND UNKNOWN/OTHER IN 6 PATIENTS. RESULTS: THIS STUDY INVOLVED A TOTAL OF 16,412 CATHETER DAYS. THERE WERE 95 EPISODES OF CRB (CATHETER RELATED BACTEREMIA) IN 45 CHILDREN. THERE WERE 3 CASES OF FUNGEMIA WITH CANDIDA ALBICANS AND CANDIDA TROPICALIS. THERE WERE NO ALLERGIC REACTIONS/CONTACT DERMATITIS DUE TO EITHER BETADINE® OR BIOPATCH® DURING THIS STUDY PERIOD. RANDOM SERUM TOBRAMYCIN LEVELS WERE OBTAINED 48 H AFTER THE APPLICATION OF THE FIRST ABL FOR EACH PATIENT. NONE OF THE SAMPLES REVEALED DETECTABLE SERUM TOBRAMYCIN LEVELS (REPORTED LEVEL <0.2 MG/L). FURTHER SERUM TOBRAMYCIN LEVELS WERE NOT OBTAINED. THERE WERE NO EXCESSIVE BLEEDING EPISODES IN EITHER GROUP WITH HEPARIN OR TPA/TOBRA ABL USE. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919207 BIOPATCH, UNKNOWN SIZE/PRODUCT ID ANTIMICROBIAL PRODUCTS FRO INTEGRA NEUROSCIENCES PR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other