BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3791450 · Received May 5, 2014

    Report

    Report Number
    1416980-2014-14529
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    January 23, 2014
    Report Date
    April 10, 2014
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K811078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS FOUND TO BE OF THIS LOT NUMBER UPON RECEIPT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION THE MALE LUER LOCK WAS OBSERVED TO BE BROKEN. THE REPORTED PROBLEM WAS VERIFIED. THE CAUSE OF THE PROBLEM WAS THE ALCOHOL USED TO DISINFECT CONNECTIONS, WHICH CAN ACT AS A BONDING AGENT IF NOT ALLOWED TO DRY, MAKING DISCONNECTION DIFFICULT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MALE LUER OF A NON-DEHP HIGH FLOW RATE EXTENSION SET ¿CRUMBLED APART.¿ THIS OCCURRED DURING INFUSION OF DOXORUBICIN. THE REPORTER STATED THAT THE SET WAS NOT SCREWED ON TIGHTLY AND WAS BRAND NEW. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267718 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO UR13K11018

    Patients

    Seq Age Sex Outcome Treatment
    1 DOXORUBICIN