BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CHEMOSITE

    MDR report key: 5171605 · Received October 23, 2015

    Report

    Report Number
    1219930-2015-00905
    Event Type
    Injury
    Date Received
    October 23, 2015
    Report Date
    October 19, 2015
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL ATTEMPTS TO OBTAIN INFORMATION AND THE DEVICE HAVE BEEN MADE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH NEW DETAILS IF THEY BECOME AVAILABLE. RELATED FTRS: (B)(4). ARTICLE CITATION: HSU, JUI-FENG. 2015. PORT TYPE IS A POSSIBLE RISK FACTOR FOR IMPLANTABLE VENOUS ACCESS PORT-RELATED BLOODSTREAM INFECTIONS AND NO SIGN OF LOCAL INFECTION PREDICTS THE GROWTH OF GRAM-NEGATIVE BACILLI. WORLD JOURNAL OF SURGICAL ONCOLOGY, 13:288. DOI 10.1186/S12957-015-0707-2.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE ARTICLE: VENOUS PORT IMPLANTATION IS WIDELY USED FOR THE SAFE DELIVERY OF SYSTEMIC CHEMOTHERAPY IN PATIENTS WITH CANCER. HOWEVER, VARIOUS COMPLICATIONS HAVE BEEN REPORTED WITH AN OVERALL COMPLICATION RATE RANGING FROM 0.4 TO 29 % [1-4]. THE MAJOR COMPLICATIONS OF IMPLANTABLE VENOUS ACCESS PORT (IVAP) PLACEMENT INCLUDE INFECTION, THROMBOSIS, CATHETER OBSTRUCTION, EXTRAVASATION, AND CATHETER MIGRATION [1, 5, 6], OF WHICH IVAP-RELATED INFECTION IS THE MOST COMMON. CATHETER-RELATED BLOOD STREAM INFECTIONS (BSIS) HAVE BEEN REPORTED IN 2.4 TO 16.4 % OF CASES [4, 7-11]. SEVERAL STUDIES HAVE REPORTED FACTORS THAT INCREASE INFECTIOUS PORT COMPLICATIONS, WITH ONE OF THE MOST SIGNIFICANT BEING HEMATOLOGIC MALIGNANCY. HOWEVER, TO THE BEST OF OUR KNOWLEDGE, ONLY A FEW STUDIES HAVE SYSTEMATICALLY ANALYZED THE RISK FACTORS FOR IVAP RELATED BLOOD INFECTIONS. (B)(4). REPORTED THAT PORT-ASSOCIATED INFECTIONS ARE MOSTLY OBSERVED IN YOUNGER PATIENTS WITH HEMATOLOGIC NEOPLASMS [12]. RECENTLY, (B)(4). CONCLUDED THAT HEMATOLOGIC MALIGNANCY AND RECEIVING PALLIATIVE CHEMOTHERAPY WERE INDEPENDENT RISK FACTORS FOR IVAP-RELATED BSIS [8]. IN ADDITION, A CASE CONTROL STUDY PERFORMED BY (B)(4). SHOWED THAT PROLONGED CATHETER PLACEMENT WAS A RISK FACTOR FOR CATHETER-RELATED BSIS AND THAT THE RISK WAS LOWER IN PATIENTS WITH PRIMARY GASTROINTESTINAL CANCER THAN IN OTHER TYPES OF CANCER [10]. HOWEVER, TO DATE, NO STUDIES HAVE INVESTIGATED WHETHER THE TYPE OF VENOUS POR...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702022 UNKNOWN CHEMOSITE CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS COVIDIEN, FORMERLY US SURGICAL A DIVISON UNKNOWN CHEMOSI NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention