BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP WITH POVIDONE-IODINE

    MDR report key: 2171863 · Received July 22, 2011

    Report

    Report Number
    1423500-2011-09308
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 27, 2011
    Manufacturer
    BAXTER HEALTHCARE - GUANGZHOU
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SAMPLE WAS EVALUATED BY THE COMPLAINT QUALITY ENGINEER. NO EXCEPTION WAS FOUND AFTER INSPECTION. THE CAUSE WAS UNDETERMINED. A REVIEW THE BATCH REVEALED NO EXCEPTION RELATED TO THIS ISSUE FOUND IN THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). A 510K 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 510K NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME OR SIMILAR TO THE PRODUCT DISTRIBUTED WITHIN THE U.S. THE DEVICE HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED BY BAXTER FOR EVALUATION. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A NURSE REPORTED TO BAXTER (B)(4) THAT A BLACK SPOT WAS ON TWO MINICAPS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS ADDRESSING MINICAP 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP WITH POVIDONE-IODINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - GUANGZHOU GM1101009

    Patients

    Seq Age Sex Outcome Treatment
    1