BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2082255 · Received May 9, 2011

    Report

    Report Number
    1423500-2011-05647
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 14, 2011
    Manufacturer
    BAXTER HEALTHCARE - GUANGZHOU
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RECEIVED AND EVALUATED, AND THE REPORTED ISSUE OF BROKEN MINICAP WAS CONFIRMED IN THE LAB BY VISION INSPECTION, BUT NO EXCEPTION WAS FOUND AFTER LEAKING TEST. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. THE CAUSE OF THE CRACK HAS BEEN DETERMINED TO BE RELATED TO MOLDING, WHICH WAS CAUSED BY THE MINICAP SUPPLIER DURING THE MANUFACTURING PROCESS. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    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. THE SAMPLE WAS REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT. (THIS REPORT ADDRESSES PRODUCT QUANTITY 1 OF 2.)

    Description of Event or Problem · 1

    A PATIENT REPORTED TO BAXTER (B)(4) TWO (2) BROKEN MINICAPS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - GUANGZHOU GM1101007

    Patients

    Seq Age Sex Outcome Treatment
    1