BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPATCH, UNKNOWN SIZE/PRODUCT ID

    MDR report key: 10517108 · Received September 10, 2020

    Report

    Report Number
    2648988-2020-00025
    Event Type
    Injury
    Date Received
    September 10, 2020
    Report Date
    August 18, 2020
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    FRO
    PMA / PMN Number
    K003229
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D10, G4, G7, H2, H3, H6, H10. COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ELSEVIER PUBLISHED (2020) : "INFLUENCE OF THE INSERTION SITE ON CENTRAL VENOUS CATHETER-RELATED COMPLICATIONS IN PATIENTS UNDERGOING ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANTATION". THIS RETROSPECTIVE STUDY AIMED TO SYSTEMATICALLY ANALYZE CENTRAL VENOUS CATHETERS (CVC)-RELATED COMPLICATIONS FOR THE 2 INSERTION SITES IN PATIENTS UNDERGOING ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANTATION (HCT). BETWEEN JANUARY 2011 AND JUNE 2013, A TOTAL OF 56 ADULT PATIENTS WHO UNDERWENT ALLOGENEIC HCT WERE INCLUDED IN THIS ANALYSIS (N=36 MALE, N=20 FEMALE, MEDIAN AGE: 55 YEARS, AGE RANGE: 19-74 YEARS). IN TOTAL, 101 CVCS WERE PLACED IN 56 PATIENTS, INCLUDING 60 AT THE INTERNAL JUGULAR VEIN (IJV) AND 41 IN THE SUBCLAVIAN VEIN (SCV). CVCS WERE COVERED BY CHLORHEXIDINE GLUCONATE-IMPREGNATED (CGI) DRESSINGS, EITHER AS TRANSPARENT POLYURETHANE (TEGADERM) OR AS A SPONGE DRESSING (BIOPATCH; ETHICON). ADVERSE EVENTS, LOCAL INFLAMMATION, BSI (BLOODSTREAM INFECTION), FEVER, CENTRAL LINE-ASSOCIATED BLOODSTREAM INFECTION (CLABSI). IN CONCLUSION, IN CONTRAST TO PREVIOUS STUDIES IN NONHEMATOLOGIC PATIENTS, THE PRESENT STUDY CLEARLY SHOWS THAT IN ALLOGENEIC HCT RECIPIENTS, CVC PLACEMENT IN THE SCV IS NOT SUPERIOR TO PLACEMENT IN THE IJV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980928 BIOPATCH, UNKNOWN SIZE/PRODUCT ID ANTIMICROBIAL PRODUCTS FRO INTEGRA NEUROSCIENCES PR

    Patients

    Seq Age Sex Outcome Treatment
    1