BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 3230675 · Received July 16, 2013

    Report

    Report Number
    1416980-2013-18722
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Report Date
    June 21, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPANION SAMPLES THAT WERE RETURNED FOR ANALYSIS SHOWED NO VISUAL OR FUNCTIONAL ISSUES. THE REPORTED CONDITION OF INADEQUATE IODINE WAS NOT CONFIRMED. THE CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL SAMPLE WAS NOT AVAILABLE, BUT FIVE COMPANION SAMPLES WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION FOUND NO ISSUES AND THAT THE CAPS ALL CONTAINED IODINE. PRESSURE TESTING WAS PERFORMED WITH NO ISSUES. THE COMPANION SAMPLES WERE ALL FOUND TO MEET SPECIFICATIONS. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MINICAP HAD INADEQUATE IODINE. THIS WAS NOTICED PRIOR TO USE. THE CAREGIVER (CG) STATED THAT HE NOTICED THAT THE MINICAPS DID NOT HAVE AS MUCH IODINE AS THEY DID IN PREVIOUS ORDERS. THE CG STATED THAT THE INDIVIDUAL PACKAGING ON THE CAP LOOKED SEALED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED IN ASSOCIATION WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328167 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND GD894188

    Patients

    Seq Age Sex Outcome Treatment
    1