BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2202929 · Received August 11, 2011

    Report

    Report Number
    1423500-2011-10595
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 2011
    Manufacturer
    BAXTER HEALTHCARE - GUANGZHOU
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    (B)(4). ACTUAL SAMPLE WAS VISUALLY INSPECTED AND EVALUATED. THE REPORTED PROBLEM WAS CONFIRMED . THE INSPECTION CONFIRMED THAT MINI CAP SPONGE CAME OUT FROM THE MINI CAP. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. THE ASSIGNABLE CAUSE IS MISHANDLING DURING DISTRIBUTION AND SHIPPING OR STORAGE. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    A BAXTER REPRESENTATIVE REPORTED A DAMAGED MINICAP FOUND DURING USE AT HOME BY A PATIENT. THERE IS NO PATIENT INVOLVEMENT AND NO INJURY TO PATIENT IS ASSOCIATED WITH THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDI BAXTER HEALTHCARE - GUANGZHOU GM1102001

    Patients

    Seq Age Sex Outcome Treatment
    1