BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 3110493 · Received May 14, 2013

    Report

    Report Number
    1416980-2013-12230
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    April 18, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED, THEREFORE A DEVICE ANALYSIS CANNOT BE COMPLETED. A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBER GD893735 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.

    Additional Manufacturer Narrative · 1

    (B)(4). NEW EVALUATION CODING IS BEING PROVIDED FOR THE UNUSED COMPANION DEVICE THAT WAS RECEIVED. THE ACTUAL DEVICE WAS NOT AVAILABLE FOR EVALUATION HOWEVER AN UNUSED COMPANION DEVICE WAS RECEIVED. VISUAL INSPECTION OF THE DEVICE FOUND IODINE PRESENT. THE DEVICE CONTAINING POUCH WAS PRESSURE TESTED AND NO LEAKS WERE OBSERVED IN THE POUCH. THE RETURNED DEVICE MET ALL SPECIFICATIONS. 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 VERY LITTLE VISIBLE BETADINE PRIOR TO PATIENT USE. THE NURSE REPORTED THAT THE MINICAP LOOKED "ORANGE" AND "DRY." THE NURSE STATED THAT WHEN SHE USED SOMETHING TO PRESS DOWN ON THE SPONGE INSIDE THE MINICAP, SHE SAW THAT THERE WAS BETADINE. THE NURSE INSTRUCTED HER PATIENTS NOT TO USE THE MINICAPS THAT APPEARED TO HAVE INADEQUATE BATADINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212688 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND GD893735

    Patients

    Seq Age Sex Outcome Treatment
    1