BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP DISCONNECT CAP

    MDR report key: 1230735 · Received November 17, 2008

    Report

    Report Number
    1423500-2007-00111
    Event Type
    Malfunction
    Date Received
    November 17, 2008
    Date of Event
    January 2, 2007
    Report Date
    February 6, 2007
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE NOT AVAILABLE FOR ANALYSIS; THERFORE THE LAB WAS NOT ABLE TO CONFIRM THE REPORTED EVENT. THERE ARE NO FURTHER MEASURES TAKEN RELATIVE TO THIS MATTER. RENAL PRODUCT SURVEILLANCE, QUALITY ENGINEERING, ALONG WITH PLANT MANUFACTURING, WILL CONTINUE TO MONITOR THIS PRODUCT LINE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED A BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) REGARDING THE MINICAPS FALLING OFF OF THE MINICAP TRANSFER SET. THE ISSUE WAS DETECTED BEFORE USE. SAMPLES HAVE BEEN DISCARDED. THE NURSE INDICATED THERE HAVE BEEN NO ADDITIONAL PROBLEMS WITH THE MINICAPS SINCE THIS INCIDENT AND NO FURTHER INFORMATION IS AVAILABLE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS ASSOCIATED WITH THIS INCIDENT PER THE RN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP DISCONNECT CAP DISCONNECT CAPS KDJ BAXTER HEALTHCARE CORPORATION NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1