BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING TITANIUM ADAPTER

    MDR report key: 3013394 · Received March 20, 2013

    Report

    Report Number
    1416980-2013-06743
    Event Type
    Injury
    Date Received
    March 20, 2013
    Report Date
    March 1, 2013
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONNECTION ISSUE WAS NOT CONFIRMED, BECAUSE A BATCH REVIEW AND SAMPLE EVALUATION COULD NOT BE PERFORMED TO CONFIRM THE PROBLEM. THE PATIENT REPORTED A LOOSE CONNECTED, BUT THERE IS NOT ENOUGH INFORMATION TO DETERMINE AN ASSIGNABLE CAUSE FOR THE CONNECTION ISSUE. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED A BREACH IN ASEPTIC TECHNIQUE, WHICH MAY HAVE LED TO PERITONITIS. IT WAS REPORTED THAT AIR WAS INTRODUCED AT A LOOSE CONNECTION SITE BETWEEN THE TRANSFER SET AND THE TITANIUM ADAPTOR. IT WAS NOT REPORTED IF EFFLUENT CULTURE WERE PERFORMED, HOWEVER THE REPORTED PERITONITIS WAS CLASSIFIED AS BACTERIAL PERITONITIS. TREATMENT WAS NOT REPORTED. THE PATIENT WAS RECOVERING FROM THE PERITONITIS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116743 LOCKING TITANIUM ADAPTER SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other