BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE

    MDR report key: 8654634 · Received May 30, 2019

    Report

    Report Number
    9610847-2019-00391
    Event Type
    Malfunction
    Date Received
    May 30, 2019
    Date of Event
    May 13, 2019
    Report Date
    July 26, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    30382903851004
    PMA / PMN Number
    K013621
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED A Q-SYTE CLOSED LUER DEVICE FROM LOT 8243562 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND OBSERVED THAT THE UNIT WAS BROKEN INTO TWO PIECES. THE BREAK WAS LOCATED BELOW THE NECK OF THE TOP BODY. BASED OFF THE VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THAT THERE WAS DAMAGE TO THE RETURNED UNIT. HOWEVER, SINCE THE UNIT WAS RETURNED OUTSIDE OF ITS ORIGINAL PACKAGING A DEFINITIVE CAUSE FOR THE OBSERVED DAMAGE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DAMAGED CONNECTOR OCCURRED WITH A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CONNECTOR WAS FOUDN CRACKED IN THE MIDDLE FOR UNCLEAR REASON ON THE SECOND DAY OF PLACEMENT. BLOOD CONTAMINATED THE SHEET. BASED ON COMMUNICATION WITH THE SALES REP., THE PATIENT HAS NO INFECTIOUS DISEASES OR BLOOD-BORNE DISEASES."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DAMAGED CONNECTOR OCCURRED WITH A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE CONNECTOR WAS FOUND CRACKED IN THE MIDDLE FOR UNCLEAR REASON ON THE SECOND DAY OF PLACEMENT. BLOOD CONTAMINATED THE SHEET. BASED ON COMMUNICATION WITH THE SALES REP., THE PATIENT HAS NO INFECTIOUS DISEASES OR BLOOD-BORNE DISEASES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446504 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8243562 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other