BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2101615 · Received May 25, 2011

    Report

    Report Number
    1423500-2011-06454
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 29, 2011
    Report Date
    April 29, 2011
    Manufacturer
    BAXTER HEALTHCARE - CALI
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT AVAILABLE. WITHOUT A SAMPLE IT IS NOT POSSIBLE TO DEFINE THE ROOT CAUSE THAT CAUSED THE ISSUE. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME OR SIMILAR TO THE PRODUCT DISTRIBUTED WITHIN THE U.S.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED 1 MINI CAP THAT WAS CRACKED IN THE SUPERIOR PART. PATIENT INJURY AND MEDICAL INTERVENTION WERE NOT REPORTED FOR THIS EVENT. PATIENT NOT INVOLVED. REPORT 1 OF 2

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP SYSTEM, PERITONEAL, AUTOMATIC DELIVERY KDJ BAXTER HEALTHCARE - CALI SE11CA4

    Patients

    Seq Age Sex Outcome Treatment
    1